Review Panel
Clinical Chemistry FDA 510(k) Clearances & Devices
- Cleared Devices
- 13,065
- Product Codes (page)
- 47
- Latest Decision
- 2000-11-27
Clearances · page 34 of 131
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K003093 | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 | Diagnostic Chemicals , Ltd. | CJE | Class II | 2000-11-27 |
| K002852 | N/T PROTEIN CONTROL SL | Dade Behring, Inc. | JJY | Class I | 2000-11-27 |
| K003488 | SYNCHRON CONTROL | Beckman Coulter, Inc. | JJY | Class I | 2000-11-27 |
| K001651 | BIO-RAD %CDT TIA | Axis-Shield Biochemicals, Asa | JJX | Class I | 2000-11-22 |
| DEN000010 | TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST | Biosite Incorporated | NBC | Class II | 2000-11-20 |
| K003098 | ACCESS ULTRASENSITIVE HGH CALIBRATORS | Beckman Coulter, Inc. | JIT | Class II | 2000-11-20 |
| K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET | Pointe Scientific, Inc., | CFR | Class II | 2000-11-20 |
| K003261 | CREATININE PLUS | Roche Diagnostics Corp. | JFY | Class II | 2000-11-16 |
| K001993 | SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS | Abbott Laboratories | LFR | Class II | 2000-11-13 |
| K001249 | QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 | Consolidated Technologies of Wisconsin | JJY | Class I | 2000-11-02 |
| K002456 | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 | Becton Dickinson Vacutainer Systems | JKA | Class II | 2000-11-02 |
| K001455 | ACCUWELL TSH, MODEL KAW-TSH-960 | Neometrics, Inc. | JLW | Class II | 2000-11-02 |
| K003112 | VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS | Ortho-Clinical Diagnostics, Inc. | JJX | Class I | 2000-11-02 |
| K002982 | OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | JJE | Class I | 2000-10-25 |
| K003012 | RAICHEM PHOSPORUS REAGENT | Hemagen Diagnostics, Inc. | CEO | Class I | 2000-10-25 |
| K002613 | MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER | Nova Biomedical Corp. | CHL | Class II | 2000-10-19 |
| K002855 | BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER | Biocare Corp. | JGS | Class II | 2000-10-12 |
| K002867 | INVERNESS MEDICAL OVULATION PREDICTOR TEST | Selfcare, Inc. | CEP | Class I | 2000-10-12 |
| K001603 | REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) | Repromedix Corp. | KLI | Class II | 2000-10-05 |
| K002804 | N PROTEIN STANDARD SL | Dade Behring, Inc. | JIX | Class II | 2000-10-05 |
| K002777 | VACUETTE WITH PPACK | Greiner Vacuette North America, Inc. | JKA | Class II | 2000-10-05 |
| K002760 | ELECSYS DHEA-S CALSET | Roche Diagnostics Corp. | JIS | Class II | 2000-10-05 |
| K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 | I-Stat Corp. | CGA | Class II | 2000-10-05 |
| K001607 | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | Repromedix Corp. | CDP | Class II | 2000-10-05 |
| K001606 | REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) | Repromedix Corp. | JLW | Class II | 2000-10-05 |
| K002294 | BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 | Biocheck, Inc. | CDZ | Class I | 2000-10-02 |
| K002285 | ATAC PAK ALP REAGENT KIT | Elan Diagnostics | CJE | Class II | 2000-09-26 |
| K002354 | CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 | Diagnostic Chemicals , Ltd. | KHS | Class II | 2000-09-26 |
| K002866 | LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 | Bio-Rad | JJS | Class I | 2000-09-25 |
| K002865 | LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 | Bio-Rad | JJS | Class I | 2000-09-25 |
| K002540 | BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS | Bionostics, Inc. | JJX | Class I | 2000-09-18 |
| K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | Diagnostic Chemicals , Ltd. | CDQ | Class II | 2000-09-15 |
| K002290 | ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) | Radiometer Medical A/S | CHL | Class II | 2000-09-13 |
| K001907 | CAMIT DIABETES MANAGEMENT SOFTWARE | Roche Diagnostics Corp. | CGA | Class II | 2000-09-05 |
| K002460 | LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 | Bio-Rad | JJY | Class I | 2000-08-31 |
| K002535 | LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 | Bio-Rad | JJS | Class I | 2000-08-30 |
| K002536 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) | Bio-Rad | JJS | Class I | 2000-08-30 |
| K001943 | CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY | Sangui Biotech, Inc. | NAO | Class I | 2000-08-23 |
| K001935 | ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 | Beckman Coulter, Inc. | CDZ | Class I | 2000-08-22 |
| K002148 | ELECSYS HCG TEST SYSTEM | Roche Diagnostics Corp. | DHA | Class II | 2000-08-22 |
| K002174 | DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 | Casco-Nerl Diagnostics Corporation (Maine) | JJY | Class I | 2000-08-22 |
| K002120 | LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 | Bio-Rad | JJS | Class I | 2000-08-21 |
| K001411 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 | Scantibodies Laboratory, Inc. | CEW | Class II | 2000-08-21 |
| K001810 | URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING | Flexsite Diagnostics, Inc. | JIR | Class I | 2000-08-14 |
| K001403 | SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P | Sigma Diagnostics, Inc. | CFR | Class II | 2000-08-10 |
| K002353 | ELECSYS CA 15-3 CALCHECK | Roche Diagnostics Corp. | JIS | Class II | 2000-08-10 |
| K001761 | STATLYTE NA/K/CL/LI ANALYZER | Nova Biomedical Corp. | JGS | Class II | 2000-08-07 |
| K002196 | LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 | Bio-Rad | JJY | Class I | 2000-08-07 |
| K002134 | ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM | Selfcare, Inc. | CGA | Class II | 2000-08-07 |
| K000568 | HDL CHOLESTEROL PLUS | Roche Diagnostics Corp. | LBT | Class I | 2000-08-04 |
| K002049 | INVERNESS MEDICAL EARLY PREGNANCY TEST | Selfcare, Inc. | LCX | Class II | 2000-07-27 |
| K001092 | GENERIC BLOOD GLUCOSE TEST STRIP | Inbios Intl., Inc. | CGA | Class II | 2000-07-26 |
| K993706 | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY | Roche Diagnostics Corp. | JMM | Class I | 2000-07-24 |
| K001032 | RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY | Otsuka Pharmaceutical Co., Ltd. | CHH | Class I | 2000-07-24 |
| K000610 | RESOLUTION CHOLESTEROL MONITOR | Lifestream Technologies, Inc. | CHH | Class I | 2000-07-21 |
| K001885 | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Ortho-Clinical Diagnostics, Inc. | CDN | Class II | 2000-07-20 |
| K001906 | ELECSYS INSULIN CALSET | Roche Diagnostics Corp. | JIS | Class II | 2000-07-13 |
| K001758 | DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) | Medical Analysis Systems, Inc. | JJY | Class I | 2000-07-05 |
| K000586 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | Polymer Technology Systems, Inc. | JGY | Class I | 2000-07-03 |
| K993741 | EZ LDL CHOLESTEROL TEST SYSTEM | Sigma Diagnostics, Inc. | MRR | Class I | 2000-07-03 |
| K001443 | SUGAR CHEX ONE | Streck Laboratories, Inc. | JJX | Class I | 2000-06-29 |
| K001679 | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 | Ortho-Clinical Diagnostics, Inc. | CIT | Class II | 2000-06-28 |
| K001846 | ELECSYS INSULIN CALCHECK | Roche Diagnostics Corp. | JJX | Class I | 2000-06-28 |
| K001569 | INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) | Sigma Diagnostics, Inc. | JFJ | Class II | 2000-06-26 |
| K001215 | DBEST HCG 2 IU/ML TEST KIT | Ameritek, Inc. | JHI | Class II | 2000-06-22 |
| K001769 | VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT | Ortho-Clinical Diagnostics | CGX | Class II | 2000-06-21 |
| K000754 | QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT | Quantase , Ltd. | JNB | Class II | 2000-06-19 |
| K001632 | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 | Avl Scientific Corp. | JJY | Class I | 2000-06-19 |
| K001484 | CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 | Alko Diagnostic Corp. | JIX | Class II | 2000-06-19 |
| K000844 | ABSOLUTE HCG PREGNANCY TEST | Mizuho USA, Inc. | DHA | Class II | 2000-06-16 |
| K993697 | DELFIA NEONATAL IRT KIT | Wallac OY | CGZ | Class II | 2000-06-09 |
| K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 | Diagnostic Chemicals , Ltd. | JIF | Class I | 2000-06-02 |
| K001427 | MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM | Selfcare, Inc. | CGA | Class II | 2000-06-02 |
| K001458 | SYNCHRON CONTROL | Beckman Coulter, Inc. | JJX | Class I | 2000-06-02 |
| K001014 | ELECSYS ANTI-TPO CALCHECK | Roche Diagnostics Corp. | JJX | Class I | 2000-06-01 |
| K001005 | WAKO HDL-C/LDL-C CALIBRATOR | Wako Chemicals USA, Inc. | JIS | Class II | 2000-06-01 |
| K001004 | WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR | Wako Chemicals USA, Inc. | JIS | Class II | 2000-06-01 |
| K001373 | LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 | Bio-Rad | JJY | Class I | 2000-05-25 |
| K001002 | WAKO LIPASE CALIBRATOR | Wako Chemicals USA, Inc. | JIS | Class II | 2000-05-24 |
| K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | Elan Holdings, Inc. | CDQ | Class II | 2000-05-24 |
| K991894 | BIOSCANNER TRIGLYCERIDES TEST STRIPS | Polymer Technology Systems, Inc. | JGY | Class I | 2000-05-24 |
| K001086 | FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 | Diagnostic Systems Laboratories, Inc. | CDZ | Class I | 2000-05-18 |
| K000784 | THE CARDIAC READER SYSTEM | Roche Diagnostics Corp. | MMI | Class II | 2000-05-18 |
| K000556 | ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS | Elan Diagnostics | CFR | Class II | 2000-05-17 |
| K000926 | EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER | Medica Corp. | CGZ | Class II | 2000-05-15 |
| K001310 | VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Ortho-Clinical Diagnostics, Inc. | JFY | Class II | 2000-05-05 |
| K994433 | CONNECT DATA MANAGEMENT SYSTEM | Abbott Diabetes Care, Inc. | LFR | Class II | 2000-05-05 |
| K000783 | DIRECT TIBC CALIBRATOR | Reference Diagnostics, Inc. | JIT | Class II | 2000-05-04 |
| K000900 | ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS | Elan Holdings, Inc. | CHH | Class I | 2000-05-02 |
| K001266 | VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA | Ortho-Clinical Diagnostics, Inc. | CGN | Class II | 2000-05-02 |
| K000781 | DIRECT TIBC KIT | Reference Diagnostics, Inc. | JMO | Class I | 2000-05-02 |
| K001015 | ELECSYS THYROGLOBULIN CALCHECK | Roche Diagnostics Corp. | JJX | Class I | 2000-04-27 |
| K001133 | VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | KHS | Class II | 2000-04-24 |
| K000875 | ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 | Bio-Rad | JJY | Class I | 2000-04-20 |
| K001154 | I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER | I-Stat Corp. | JGS | Class II | 2000-04-18 |
| K000874 | URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 | Bio-Rad | JJW | Class I | 2000-04-18 |
| K000043 | DRG AURICA ELISA TESTOSTERONE KIT | Drg Intl., Inc. | CDZ | Class I | 2000-04-17 |
| K000603 | SPIFE CHOLESTEROL PROFILE KIT | Helena Laboratories | JHO | Class I | 2000-04-17 |
| K000895 | STAT PROFILE PHOX PLUS ANALYZER | Nova Biomedical Corp. | JGS | Class II | 2000-04-17 |
| K993787 | APPRAISE-CARDIO SAMPLE COLLECTION KIT | Osborn Group, Inc. | JKA | Class II | 2000-04-14 |
13,065 clearances in the Clinical Chemistry panel. Data: openFDA.