FDA Product Code
FDA Product Code JJX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 493 records · page 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K022769 | LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION | Bionostics, Inc. | 2002-11-13 | Traditional | PDF ↗ |
| K023307 | MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL | Medical Analysis Systems, Inc. | 2002-10-31 | Traditional | PDF ↗ |
| K022725 | CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 | Good Biotech Corp. | 2002-09-23 | Traditional | PDF ↗ |
| K022758 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER | Cliniqa Corporation | 2002-09-17 | Traditional | PDF ↗ |
| K022491 | LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS | Cliniqa Corporation | 2002-08-27 | Traditional | PDF ↗ |
| K022232 | CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 | Cliniqa Corporation | 2002-08-01 | Traditional | PDF ↗ |
| K021697 | GLUCOSE CONTROL SOLUTION FOR BD LATITUDE | Bionostics, Inc. | 2002-07-12 | Traditional | PDF ↗ |
| K021624 | RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4 | Bionostics, Inc. | 2002-07-12 | Traditional | PDF ↗ |
| K020217 | ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY | Bayer Diagnostics Corp. | 2002-03-15 | Traditional | PDF ↗ |
| K020369 | ELECSYS ANTI-TG CALCHECK | Roche Diagnostics Corp. | 2002-03-06 | Traditional | PDF ↗ |
| K013900 | VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS | Ortho-Clinical Diagnostics | 2001-12-21 | Traditional | PDF ↗ |
| K013119 | VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 | Maine Standards Co. | 2001-11-16 | Traditional | PDF ↗ |
| K013147 | GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE | Bionostics, Inc. | 2001-10-24 | Traditional | PDF ↗ |
| K013130 | N LP(A) CONTROL SY | Dade Behring, Inc. | 2001-10-18 | Traditional | PDF ↗ |
| K012561 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS | Ortho-Clinical Diagnostics | 2001-08-29 | Traditional | PDF ↗ |
| K012430 | MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 | Bionostics, Inc. | 2001-08-27 | Traditional | PDF ↗ |
| K012122 | VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 | Maine Standards Co. | 2001-08-20 | Traditional | PDF ↗ |
| K011250 | VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS | Ortho-Clinical Diagnostics, Inc. | 2001-06-13 | Traditional | PDF ↗ |
| K011463 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS | Ortho-Clinical Diagnostics | 2001-06-13 | Special | PDF ↗ |
| K010693 | VIGIL DNASE B CONTROL | Beckman Coulter, Inc. | 2001-04-11 | Traditional | PDF ↗ |
| K010428 | ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 | Beckman Coulter, Inc. | 2001-03-13 | Traditional | PDF ↗ |
| K010237 | ELECSYS HCG+B CALCHECK | Roche Diagnostics Corp. | 2001-02-14 | Traditional | PDF ↗ |
| K003967 | CA 125 II CALCHECK | Roche Diagnostics Corp. | 2001-01-12 | Special | PDF ↗ |
| K003772 | ELECSYS DHEA-S CALCHECK | Roche Diagnostics Corp. | 2000-12-20 | Traditional | PDF ↗ |
| K003095 | FASTPACK CONTROL | Qualigen, Inc. | 2000-11-29 | Abbreviated | PDF ↗ |
| K001651 | BIO-RAD %CDT TIA | Axis-Shield Biochemicals, Asa | 2000-11-22 | Traditional | PDF ↗ |
| K003112 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS | Ortho-Clinical Diagnostics, Inc. | 2000-11-02 | Traditional | PDF ↗ |
| K002540 | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS | Bionostics, Inc. | 2000-09-18 | Traditional | PDF ↗ |
| K001443 | SUGAR CHEX ONE | Streck Laboratories, Inc. | 2000-06-29 | Traditional | PDF ↗ |
| K001846 | ELECSYS INSULIN CALCHECK | Roche Diagnostics Corp. | 2000-06-28 | Traditional | PDF ↗ |
| K001458 | SYNCHRON CONTROL | Beckman Coulter, Inc. | 2000-06-02 | Special | PDF ↗ |
| K001014 | ELECSYS ANTI-TPO CALCHECK | Roche Diagnostics Corp. | 2000-06-01 | Traditional | PDF ↗ |
| K001015 | ELECSYS THYROGLOBULIN CALCHECK | Roche Diagnostics Corp. | 2000-04-27 | Traditional | PDF ↗ |
| K992781 | ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 | Bio-Rad | 2000-04-05 | Traditional | PDF ↗ |
| K000042 | ELECSYS B-CROSSLAPS CALCHECK | Roche Diagnostics Corp. | 2000-03-17 | Traditional | PDF ↗ |
| K000231 | TRIAGE BNP CALIBRATION VERIFICATION CONTROLS | Biosite Incorporated | 2000-03-02 | Traditional | PDF ↗ |
| K000230 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS | Biosite Incorporated | 2000-02-29 | Traditional | PDF ↗ |
| K000318 | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Bionostics, Inc. | 2000-02-28 | Traditional | PDF ↗ |
| K000056 | BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS | Biocell Laboratories, Inc. | 2000-02-24 | Traditional | PDF ↗ |
| K994200 | ACCESS HYBRITECH PSA QC, MODEL 37209 | Beckman Coulter, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K994277 | ACCESS OSTASE QC | Beckman Coulter, Inc. | 2000-01-14 | Traditional | PDF ↗ |
| K993210 | ACCESS HYBRITECH FREE PSA QC, MODEL 37219 | Beckman Coulter, Inc. | 2000-01-05 | Traditional | PDF ↗ |
| K993642 | ELECSYS PARATHYROID HORMONE CALCHECK | Roche Diagnostics Corp. | 1999-11-30 | Traditional | PDF ↗ |
| K981914 | TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION | The Binding Site, Ltd. | 1999-11-26 | Traditional | PDF ↗ |
| K991075 | ATLAST GLUCOSE CONTROL SOLUTION | Amira Medical, Inc. | 1999-05-10 | Traditional | PDF ↗ |
| K990984 | VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 1999-04-08 | Traditional | PDF ↗ |
| K990608 | ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 | Bio-Rad | 1999-03-30 | Traditional | PDF ↗ |
| K990783 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 1999-03-25 | Traditional | PDF ↗ |
| K990393 | ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 | Bio-Rad | 1999-03-22 | Traditional | PDF ↗ |
| K990755 | SAS HCG URINE CONTROLS | Sa Scientific, Inc. | 1999-03-19 | Traditional | PDF ↗ |
| K990720 | SAS HCG SERUM CONTROLS | Sa Scientific, Inc. | 1999-03-19 | Traditional | PDF ↗ |
| K984625 | ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 | Bio-Rad | 1999-02-02 | Traditional | PDF ↗ |
| K984604 | ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 | Bio-Rad | 1999-02-02 | Traditional | PDF ↗ |
| K984626 | ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 | Bio-Rad | 1999-01-29 | Traditional | PDF ↗ |
| K990026 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K990162 | ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 | Bio-Rad | 1999-01-28 | Traditional | PDF ↗ |
| K990061 | VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 1999-01-25 | Traditional | PDF ↗ |
| K984319 | ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K984327 | ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 | Bio-Rad | 1998-12-22 | Traditional | PDF ↗ |
| K983432 | SUPREME II CONTROL SOLUTIONS | Chronimed, Inc. | 1998-12-17 | Traditional | PDF ↗ |
| K984324 | ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 | Bio-Rad | 1998-12-15 | Traditional | PDF ↗ |
| K984323 | ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 | Bio-Rad | 1998-12-15 | Traditional | PDF ↗ |
| K984318 | ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 | Bio-Rad | 1998-12-15 | Traditional | PDF ↗ |
| K984011 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS | Ortho-Clinical Diagnostics, Inc. | 1998-12-07 | Traditional | PDF ↗ |
| K984071 | LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 | Bio-Rad | 1998-12-03 | Traditional | PDF ↗ |
| K984073 | ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 | Bio-Rad | 1998-11-25 | Traditional | PDF ↗ |
| K984070 | ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 | Bio-Rad | 1998-11-25 | Traditional | PDF ↗ |
| K984072 | ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 | Bio-Rad | 1998-11-24 | Traditional | PDF ↗ |
| K983971 | CARDIAC MARKER CONTROL MODULE, MODEL CCCM | Diagnostic Products Corp. | 1998-11-18 | Traditional | PDF ↗ |
| K983578 | ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 | Bio-Rad | 1998-11-12 | Traditional | PDF ↗ |
| K982471 | B2-MICROGLOBULIN CONTROL SET SERUM | Boehringer Mannheim Corp. | 1998-08-06 | Traditional | PDF ↗ |
| K982591 | DADE TRU-LIQUID CARDIAC CONTROL | Dade Behring, Inc. | 1998-08-05 | Traditional | PDF ↗ |
| K982022 | VIGIL HEMOGLOBIN (HBALC) CONTROLS | Beckman Coulter, Inc. | 1998-07-06 | Traditional | PDF ↗ |
| K981864 | ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 | Beckman Coulter, Inc. | 1998-06-12 | Traditional | PDF ↗ |
| K981622 | DADE TRU-LIQUID CARDIAC CONTROL | Dade Behring, Inc. | 1998-06-08 | Traditional | PDF ↗ |
| K981281 | ELECSYS CALCHECK FERRITIN | Roche Diagnostics GmbH | 1998-04-24 | Traditional | PDF ↗ |
| K981278 | ELECSYS CALCHECK CA 125II | Roche Diagnostics GmbH | 1998-04-23 | Traditional | PDF ↗ |
| K974811 | ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL | Boston Biomedica, Inc. | 1998-02-10 | Traditional | PDF ↗ |
| K974644 | VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS | Johnson & Johnson Clinical Diagnostics, Inc. | 1998-01-13 | Traditional | PDF ↗ |
| K974609 | REP CHOLESTEROL PROFILE CONTROL-II | Helena Laboratories | 1998-01-06 | Traditional | PDF ↗ |
| K973676 | PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH | Sorrento Biochemical, Inc. | 1997-12-16 | Traditional | PDF ↗ |
| K973678 | ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH | Sorrento Biochemical, Inc. | 1997-12-15 | Traditional | PDF ↗ |
| K973677 | DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH | Sorrento Biochemical, Inc. | 1997-12-15 | Traditional | PDF ↗ |
| K974383 | ELECSYS CALCHECK VITAMIN B12 | Boehringer Mannheim Corp. | 1997-12-08 | Traditional | PDF ↗ |
| K974108 | SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE) | Quidel Corp. | 1997-11-26 | Traditional | PDF ↗ |
| K973832 | OPUS HLH CONTROLS | Behring Diagnostics, Inc. | 1997-10-27 | Traditional | PDF ↗ |
| K973358 | MYOGLOBIN CONTROL SET | Boehringer Mannheim Corp. | 1997-10-06 | Traditional | PDF ↗ |
| K973099 | PROSTATE SPECIFIC ANTIGEN CONTROL | Dade Chemistry Systems, Inc. | 1997-09-29 | Traditional | PDF ↗ |
| K973072 | WAKO NEFA LINEARITY SET | Wako Chemicals USA, Inc. | 1997-09-12 | Traditional | PDF ↗ |
| K972721 | ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P | Roche Diagnostic Systems, Inc. | 1997-08-06 | Traditional | PDF ↗ |
| K972687 | CARDIAC STATUS CONTROLS/TROPONIN I | Spectral Diagnostics, Inc. | 1997-07-28 | Traditional | PDF ↗ |
| K972287 | DADE TRU-LIQUID BILIRUBIN CONTROL | Dade Intl., Inc. | 1997-07-07 | Traditional | PDF ↗ |
| K971014 | LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS | Lifescan, Inc. | 1997-04-23 | Traditional | PDF ↗ |
| K970778 | LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 | More Diagnostics | 1997-04-17 | Traditional | PDF ↗ |
| K971051 | IMMULITE THYROID AUTOANTIBODY CONTROL MODULE | Diagnostic Products Corp. | 1997-04-10 | Traditional | PDF ↗ |
| K970984 | THE ELECSYS CALCHECK PROGESTERONE | Boehringer Mannheim Corp. | 1997-04-02 | Traditional | PDF ↗ |
| K970452 | ELECSYS CALCHECK CEA | Boehringer Mannheim Corp. | 1997-03-06 | Traditional | PDF ↗ |
| K970459 | ELECSYS CALCHECK CEA | Boehringer Mannheim Corp. | 1997-03-06 | Traditional | PDF ↗ |
| K970458 | ELECSYS CALCHECK PSA | Boehringer Mannheim Corp. | 1997-03-06 | Traditional | PDF ↗ |
| K970527 | ABBOTT HCG SERUM CONTROLS | Abbott Laboratories | 1997-03-03 | Traditional | PDF ↗ |
Product code JJX · Class I · Clinical Chemistry. Data: openFDA.