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 5 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K922904 | RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II | Reagents Applications, Inc. | 1992-07-30 | Traditional | PDF ↗ |
| K921252 | TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL | Hybritech, Inc. | 1992-07-17 | Traditional | PDF ↗ |
| K920556 | TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET | Hybritech, Inc. | 1992-07-17 | Traditional | PDF ↗ |
| K921089 | LYPHOCHEK(R) FRUCTOSAMINE CONTROL | Bio-Rad | 1992-04-29 | Traditional | PDF ↗ |
| K921206 | HCG CONTROL | Polymedco, Inc. | 1992-04-29 | Traditional | PDF ↗ |
| K915325 | TSH CONTROL | Polymedco, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K915806 | MILENIA DATA REDUCTION | Diagnostic Products Corp. | 1992-01-30 | Traditional | PDF ↗ |
| K914809 | MP MINI PHOTOMETER | Artel, Inc. | 1992-01-27 | Traditional | PDF ↗ |
| K913585 | LIPASE LINEARITY CONTROL | Creative Laboratory Products, Inc. | 1991-10-21 | Traditional | PDF ↗ |
| K913346 | QUANTIMETRIX AMMONIA CONTROLS | Quantimetrix Corp. | 1991-09-25 | Traditional | PDF ↗ |
| K913792 | HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL | Hichem Diagnostics | 1991-09-25 | Traditional | PDF ↗ |
| K913496 | CHOLINESTERASE LINEARITY CONTROL | Creative Laboratory Products, Inc. | 1991-09-11 | Traditional | PDF ↗ |
| K912439 | TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET | Hybritech, Inc. | 1991-08-28 | Traditional | PDF ↗ |
| K911664 | DIRECTIGEN 1-2-3 PREGNANCY CONTROLS | Quidel Corp. | 1991-05-31 | Traditional | PDF ↗ |
| K911176 | ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I | Analytical Control Systems, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K911178 | ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III | Analytical Control Systems, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K911177 | ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II | Analytical Control Systems, Inc. | 1991-05-01 | Traditional | PDF ↗ |
| K905280 | BIOTROL BILIRUBIN C & T CONTROL | Biotrol, USA, Inc. | 1991-02-04 | Traditional | PDF ↗ |
| K904503 | SERACON CR REFERENCE | Bhp Diagnostix, Inc. | 1990-11-02 | Traditional | PDF ↗ |
| K904306 | DUPONT DRUG CALIBRATOR-A | E.I. Dupont DE Nemours & Co., Inc. | 1990-10-15 | Traditional | PDF ↗ |
| K903147 | CHEM-CHEX-ALT | Streck Laboratories, Inc. | 1990-08-09 | Traditional | PDF ↗ |
| K902569 | PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF | Boehringer Mannheim Corp. | 1990-08-09 | Traditional | PDF ↗ |
| K902760 | AMERSHAM TSH CONTROL SERA | Amersham Corp. | 1990-07-27 | Traditional | PDF ↗ |
| K902867 | CHEM-CHEX BILIRUBIN | Streck Laboratories, Inc. | 1990-07-16 | Traditional | PDF ↗ |
| K900719 | ROTAG CONTROLS | Roche Diagnostic Systems, Inc. | 1990-05-30 | Traditional | PDF ↗ |
| K896875 | POSITIVE AND NEGATIVE HCG SERUM CONTROLS | Armkel, LLC | 1990-02-26 | Traditional | PDF ↗ |
| K895528 | GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 | Helena Laboratories | 1989-10-25 | Traditional | PDF ↗ |
| K894400 | MICRO-PLATE READER, MDX-1 | Medix Biotech, Inc. | 1989-10-23 | Traditional | PDF ↗ |
| K894804 | SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) | Lifescan, Inc. | 1989-09-28 | Traditional | PDF ↗ |
| K894329 | RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL | Amersham Corp. | 1989-09-05 | Traditional | PDF ↗ |
| K894181 | POSITIVE AND NEGATIVE HCG URINE CONTROLS | Armkel, LLC | 1989-08-31 | Traditional | PDF ↗ |
| K891475 | LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3 | Bio-Rad | 1989-08-01 | Traditional | PDF ↗ |
| K893140 | DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET | Casco Standards | 1989-06-23 | Traditional | PDF ↗ |
| K885282 | ASSAYED CHOLINESTERASE CONTROL | Actio, Inc. | 1989-06-09 | Traditional | PDF ↗ |
| K892656 | DRI-DYE CHECK STRIPS (TM)-405 | Awareness Technology, Inc. | 1989-05-22 | Traditional | PDF ↗ |
| K883741 | QTEST PREGNANCY TEST CONTROL | Quidel Corp. | 1988-10-03 | Traditional | PDF ↗ |
| K883316 | QUIDEL PREGNANCY TEST CONTROL | Quidel Corp. | 1988-09-22 | Traditional | PDF ↗ |
| K881430 | LIQUI-SERA SERUM ALCOHOL CONTROLS | Biodiagnostic Intl | 1988-07-08 | Traditional | PDF ↗ |
| K880039 | AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665 | Sigma Diagnostics, Inc. | 1988-02-24 | Traditional | PDF ↗ |
| K873342 | BILE ACIDS CONTROLS | Sigma Diagnostics, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K873450 | TRI-LEVEL LIGAND CONTROL | Ciba Corning Diagnostics Corp. | 1987-09-21 | Traditional | PDF ↗ |
| K873105 | REFLO-CHEX, A CHOLESTEROL REFERENCE CONTROL | Streck Laboratories, Inc. | 1987-09-16 | Traditional | PDF ↗ |
| K870151 | TOTAL/IGE THEOPHYLLINE CONTROL SERA | 3M Company | 1987-03-12 | Traditional | PDF ↗ |
| K863744 | HCG CONTROL KIT | Monoclonal Antibodies, Inc. | 1986-11-05 | Traditional | PDF ↗ |
| K863126 | TESTPACK ACUTE HCG SERUM CONTROLS | Abbott Laboratories | 1986-09-15 | Traditional | PDF ↗ |
| K861221 | EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST | Em Diagnostic Systems, Inc. | 1986-04-24 | Traditional | PDF ↗ |
| K860453 | ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 | Sigma Diagnostics, Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K855225 | ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL | Boehringer Mannheim Corp. | 1986-01-17 | Traditional | PDF ↗ |
| K853553 | DIASCAN CONTROL | Home Diagnostics, Inc. | 1985-09-16 | Traditional | PDF ↗ |
| K851042 | SUGAR-CHEX | Streck Laboratories, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K851043 | SUGAR-CHEX II | Streck Laboratories, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K851079 | BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3 | Beckman Instruments, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K843569 | PRECISET AMMONIA | Boehringer Mannheim Corp. | 1984-09-28 | Traditional | PDF ↗ |
| K833898 | TRI-LEVEL BILIRUBIN CONTROLS | Sandare Chemical Co., Inc. | 1984-01-13 | Traditional | PDF ↗ |
| K833097 | CHEM TRAK LIQUID BILIRUBIN CONTROL | Medical Analysis Systems, Inc. | 1984-01-11 | Traditional | PDF ↗ |
| K831523 | BETA SCAN NORMAL CONTROL SOLUTION | Orange Medical Instruments, Inc. | 1983-07-19 | Traditional | PDF ↗ |
| K831527 | SPINAL FLUID TOTAL PROTEIN CONTROL | Quantimetrix Corp. | 1983-07-18 | Traditional | PDF ↗ |
| K830493 | PROTOPORPHYRIN ZN CONTROL | Kaulson Laboratories, Inc. | 1983-04-18 | Traditional | PDF ↗ |
| K823421 | PHADEBAS HUMYLASE CONTROL(H) | Pharmacia, Inc. | 1983-04-05 | Traditional | PDF ↗ |
| K830204 | DAC-CEL DIAGNATAL HCG STANDARDS RD49 | Wellcome Diagnostics | 1983-02-18 | Traditional | PDF ↗ |
| K823687 | BIO INTERFERENCE BLANKING MATERIAL | American Monitor Corp. | 1983-01-07 | Traditional | PDF ↗ |
| K823186 | ESTROCEPT STABILIZED ESTROGEN RECEPTOR | Brl | 1983-01-07 | Traditional | PDF ↗ |
| K822219 | HUMAN PLASMA CONTROL FOR CEA-ROCHE | Hoffmann-La Roche, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823353 | CARCINO-CEK | Biologics Intl., Inc. | 1982-12-14 | Traditional | PDF ↗ |
| K822938 | PHADEBASE HUMYLASE CONTROL | Pharmacia, Inc. | 1982-11-05 | Traditional | PDF ↗ |
| K822698 | GLUCOSCAN CONTROLS | Lifescan, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K821742 | POSITIVE & NEGATIVE HCG URINE CONTROLS | Armkel, LLC | 1982-07-02 | Traditional | PDF ↗ |
| K821558 | LEVEL II CONTROL SERUM | Irvine Scientific | 1982-07-02 | Traditional | PDF ↗ |
| K820772 | FETAL-TEK CONTROL (IMMATURE/BORDERLINE) | Helena Laboratories | 1982-05-12 | Traditional | PDF ↗ |
| K812690 | C-PEPTIDE CONTROL PACK | Mallinckrodt Critical Care | 1981-10-06 | Traditional | PDF ↗ |
| K811912 | HELENA VMA-SMC CONTROL | Helena Laboratories | 1981-07-23 | Traditional | PDF ↗ |
| K811832 | PRECINORM U & PRECIPATH U HUMAN SERUM | Boehringer Mannheim Corp. | 1981-07-15 | Traditional | PDF ↗ |
| K811150 | URINE PREGNANCY TEST STANDARD/CONTR. PK | Mallinckrodt Critical Care | 1981-05-15 | Traditional | PDF ↗ |
| K802997 | HDL-CHOLESTEROL CONTROL SERUM | Isolab, Inc. | 1980-12-22 | Traditional | PDF ↗ |
| K802068 | ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO | Beckman Instruments, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K801854 | SPINAL FLUID CONTROL(HUMAN) | Environmental Chemical Specialties | 1980-09-16 | Traditional | PDF ↗ |
| K800708 | CODE QAS.105 PROLACTIN CONTROL SERA | Amersham Corp. | 1980-04-16 | Traditional | PDF ↗ |
| K800035 | PENTEX LIPOPROTEIN CHOLESTEROL SOLU. | Miles Laboratories, Inc. | 1980-01-21 | Traditional | PDF ↗ |
| K792524 | CK-MB (CREATINE KINASE-MB) RIA CONTROL | Mallinckrodt Critical Care | 1980-01-16 | Traditional | PDF ↗ |
| K791957 | SERACON -LO DO26 | Bhp Diagnostix, Inc. | 1979-10-11 | Traditional | PDF ↗ |
| K791141 | BILIRUBIN CALIBRATOR CONTROL | Beckman Instruments, Inc. | 1979-08-10 | Traditional | PDF ↗ |
| K791031 | ABNORMAL PROTEIN ELECTROPHORESIS CONTROL | Beckman Instruments, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K791029 | NORMAL PROTEIN ELECTROPHORESIS CONTROL | Beckman Instruments, Inc. | 1979-07-17 | Traditional | PDF ↗ |
| K790376 | DUPONT ACA CKMB VERIFIERS | E.I. Dupont DE Nemours & Co., Inc. | 1979-04-04 | Traditional | PDF ↗ |
| K790129 | SERUM PAK, HCG CONTROL | Mallinckrodt Critical Care | 1979-03-21 | Traditional | PDF ↗ |
| K782170 | SERACON-LP | Bhp Diagnostix, Inc. | 1979-02-15 | Traditional | PDF ↗ |
| K782171 | SERACON-HDL | Bhp Diagnostix, Inc. | 1979-02-08 | Traditional | PDF ↗ |
| K772285 | ACA LIPASE VERIFIERS | E.I. Dupont DE Nemours & Co., Inc. | 1978-01-06 | Traditional | PDF ↗ |
| K771798 | ACA BILIRUBIN CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | 1977-10-28 | Traditional | PDF ↗ |
| K771657 | EMIT THYROXINE CONTROL | Syva Co. | 1977-10-13 | Traditional | PDF ↗ |
| K770795 | SHAVE PREP SET | Lukens Corp. | 1977-07-11 | Traditional | PDF ↗ |
| K760885 | KETOTROL-E | Sigma Chemical Co. | 1976-11-05 | Traditional | PDF ↗ |
| K760449 | LIPID CONTROL | Sigma Chemical Co. | 1976-10-29 | Traditional | PDF ↗ |
Product code JJX · Class I · Clinical Chemistry. Data: openFDA.