FDA Product Code
FDA Product Code CFT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1625
510(k) Clearances — 80 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | Monobind | 1997-06-24 | Traditional | PDF ↗ |
| K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K970188 | SEALITE SCIENCES, INC. AQUALITE PROLACTIN | Sealite Sciences, Inc. | 1997-02-20 | Traditional | PDF ↗ |
| K964748 | ELECSYS PROLACTIN ASSAY | Boehringer Mannheim Corp. | 1997-01-21 | Traditional | PDF ↗ |
| K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 | Diagnostic Systems Laboratories, Inc. | 1996-04-26 | Traditional | PDF ↗ |
| K960060 | DSL ACTIVE PROLACTIN IRMA | Diagnostic Systems Laboratories, Inc. | 1996-02-29 | Traditional | PDF ↗ |
| K954680 | ACCESS PROLACTIN ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1995-10-20 | Traditional | PDF ↗ |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-10-03 | Traditional | PDF ↗ |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-09-25 | Traditional | PDF ↗ |
| K944698 | AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 | Organon Teknika Corp. | 1995-03-21 | Traditional | PDF ↗ |
| K943811 | ENZYME-LINKED FLUORESCENT IMMUNOASSAY | Biomerieux Vitek, Inc. | 1994-11-02 | Traditional | PDF ↗ |
| K935675 | AXSYM PROLACTIN | Abbott Laboratories | 1994-06-21 | Traditional | PDF ↗ |
| K941220 | DUPONT ACA PLUS PROLACTIN (PROL) METHOD | Dupont Medical Products | 1994-06-03 | Traditional | PDF ↗ |
| K941175 | ACCESS PROLACTIN | Bio-Rad Laboratories, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K930305 | COBAS CORE PROLACTIN EIA | Roche Diagnostic Systems, Inc. | 1993-08-19 | Traditional | PDF ↗ |
| K926386 | VISTA PROLACTIN ASSAY | Syva Co. | 1993-03-29 | Traditional | PDF ↗ |
| K925846 | IMMULITE PROLACTIN | Diagnostic Products Corp. | 1993-03-05 | Traditional | PDF ↗ |
| K922715 | IMMUCHEM PRL-MW ELISA | Icn Biomedicals, Inc. | 1992-10-05 | Traditional | PDF ↗ |
| K922170 | AMERLITE PROLACTIN-30 ASSAY | Eastman Kodak Company | 1992-09-02 | Traditional | PDF ↗ |
| K920921 | ELISA TUBE PROLACTIN TEST KIT | Bio Clinic Co. | 1992-04-08 | Traditional | PDF ↗ |
| K920345 | PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) | Medix Biotech, Inc. | 1992-03-18 | Traditional | PDF ↗ |
| K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 | Amersham Corp. | 1992-02-18 | Traditional | PDF ↗ |
| K914107 | PROLACTIN IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-09-30 | Traditional | PDF ↗ |
| K913280 | OPUS(R) PROLACTIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K904714 | CIBA CORNING ACS PROLACTIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1990-11-07 | Traditional | PDF ↗ |
| K904483 | ELEGANCE PROLACTIN ELISA | Bioclone Australia Pty , Ltd. | 1990-11-05 | Traditional | PDF ↗ |
| K904458 | LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION | London Diagnostics, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K902698 | AFFINITY PROLACTIN TEST SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-07-19 | Traditional | PDF ↗ |
| K901673 | PROLACTIN (LACTOGEN) TEST SYSTEM | Baxter Healthcare Corp | 1990-06-12 | Traditional | PDF ↗ |
| K901578 | COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2 | Diagnostic Products Corp. | 1990-04-19 | Traditional | PDF ↗ |
| K900695 | ENZYMUN TEST(R) PROLACTIN | Boehringer Mannheim Corp. | 1990-03-30 | Traditional | PDF ↗ |
| K896162 | ABBOTT IMX PROLACTIN | Abbott Laboratories | 1990-01-19 | Traditional | PDF ↗ |
| K896641 | MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K895380 | SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-10-17 | Traditional | PDF ↗ |
| K894988 | CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1989-10-12 | Traditional | PDF ↗ |
| K895003 | MILENIA(TM) PROLACTIN (MKPR1,5) | Diagnostic Products Corp. | 1989-09-18 | Traditional | PDF ↗ |
| K883878 | AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) | Amersham Corp. | 1988-11-01 | Traditional | PDF ↗ |
| K883747 | IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES | Diagnostic Products Corp. | 1988-11-01 | Traditional | PDF ↗ |
| K883269 | PRL-QUANT | Leeco Diagnostics, Inc. | 1988-09-13 | Traditional | PDF ↗ |
| K881774 | PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-06-08 | Traditional | PDF ↗ |
| K880296 | LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY | London Diagnostics, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K880218 | BINAX PROLACTIN IRMA DIAGNOSTIC KIT | Binax, Inc. | 1988-03-01 | Traditional | PDF ↗ |
| K874621 | FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 | Cyberfluor, Inc. | 1988-01-11 | Traditional | PDF ↗ |
| K873355 | MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT | Medix Biotech, Inc. | 1987-10-09 | Traditional | PDF ↗ |
| K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA | Serono Diagnostics, Inc. | 1987-09-25 | Traditional | PDF ↗ |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | Serono Diagnostics, Inc. | 1987-09-18 | Traditional | PDF ↗ |
| K871542 | HPROLACTIN KIT | Immuchem Corp. | 1987-05-14 | Traditional | PDF ↗ |
| K864439 | BECKMAN EPSILON(TM) PROLACTIN TEST KIT | Beckman Instruments, Inc. | 1987-01-21 | Traditional | PDF ↗ |
| K864075 | UBI MAGIWEL(TM) PROLACTIN QUANTATIVE | United Biotech, Inc. | 1986-12-16 | Traditional | PDF ↗ |
| K863860 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN | Hybritech, Inc. | 1986-11-21 | Traditional | PDF ↗ |
| K863240 | PROLACTIN RIABEAD II DIAGNOSTIC KIT | Abbott Laboratories | 1986-09-29 | Traditional | PDF ↗ |
| K860823 | ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT | Cis-Us, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K861271 | SUCROSEP HUMAN PROLACTIN (HPR) IRMA | Boots-Celltech Diagnostics, Inc. | 1986-06-27 | Traditional | PDF ↗ |
| K861542 | DELFIA (TM) HUMAN PROLACTIN | Lkb Instruments, Inc. | 1986-06-17 | Traditional | PDF ↗ |
| K861945 | LEE-BEAD PROLACTIN (EIA) | Leeco Diagnostics, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K860221 | ENCORE PROLACTIN REAGENT | Hybritech, Inc. | 1986-03-05 | Traditional | PDF ↗ |
| K854805 | ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM | Nichols Institute Diagnostics | 1986-01-28 | Traditional | PDF ↗ |
| K854768 | TERUMO SENSIBEAD EIA HPRL KIT | Terumo Medical Corp. | 1986-01-13 | Traditional | PDF ↗ |
| K851330 | PROLACTIN SYSTEM BY RIA | American Bioclinical, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K850383 | PRL QUIK RIA KIT | Pacific Biotech, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K843804 | TANDEM - EPRL | Hybritech, Inc. | 1984-11-13 | Traditional | PDF ↗ |
| K842478 | PROLACTIN IRMA | Euro-Diagnostics BV | 1984-09-14 | Traditional | PDF ↗ |
| K841118 | PROLACTIN RIABEAD PROLACTIN RADIOIMM | Abbott Laboratories | 1984-05-11 | Traditional | PDF ↗ |
| K833925 | COAT-A-COUNT NHS-PROLACTIN KIT AND | Diagnostic Products Corp. | 1984-01-24 | Traditional | PDF ↗ |
| K831345 | RIANEN PROLACTIN 125I KIT | New England Nuclear | 1983-06-08 | Traditional | PDF ↗ |
| K830412 | RADIOIMMUNOASSAY TEST SYSTEM PRL | Monobind | 1983-04-05 | Traditional | PDF ↗ |
| K823304 | RIASET PROLACTIN RIA KIT | Immulok, Inc. | 1982-12-22 | Traditional | PDF ↗ |
| K822759 | ABBOTT LABORATORIES PROLACTIN EIA | Abbott Laboratories | 1982-10-21 | Traditional | PDF ↗ |
| K821545 | TANDEM PROLACTIN KIT | Hybritech, Inc. | 1982-06-11 | Traditional | PDF ↗ |
| K821305 | PROLACTIN (125-I) RADIOIMMUNOASSAY KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-05-24 | Traditional | PDF ↗ |
| K813572 | CENTRIA PROLACTIN TEST SET | Ventrex Laboratories, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K820039 | LEECO PRL-QUANT DIAGNOSTIC TEST KIT | Leeco Diagnostics, Inc. | 1982-01-22 | Traditional | PDF ↗ |
| K812112 | MARRIA-HPRL RIA KIT | Intl. Immunoassay Laboratories, Inc. | 1981-08-13 | Traditional | PDF ↗ |
| K810949 | MRI PROLACTIN RIA KIT | Microanalytic Research, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K803273 | PROLACTIN (125) RADIOIMMUNAOASSAY | Corning Medical & Scientific | 1981-01-16 | Traditional | PDF ↗ |
| K801849 | LACTI-QUANT | Nuclear Medical Laboratories, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K801020 | GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- | Travenol Laboratories, S.A. | 1980-07-08 | Traditional | PDF ↗ |
| K800740 | PROLACTIN RIA KIT | Amersham Corp. | 1980-04-16 | Traditional | PDF ↗ |
| K792166 | 125 I PROLACTIN HORMONE RIA KIT | Diagnostic Products Corp. | 1979-11-13 | Traditional | PDF ↗ |
| K790003 | RIA KIT, PROLACTIN | Cis Radiopharmaceuticals, Inc. | 1979-03-12 | Traditional | PDF ↗ |
Product code CFT · Class I · Clinical Chemistry. Data: openFDA.