Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CFT — Predicate Candidate Screening
80 FDA 510(k) clearances under this product code; the 50 most recent screened below.
49 daysmedian FDA review time
107 days90th percentile
80clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | Monobind | 1997-06-24 | 32 | 0 |
| K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALI | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-25 | 32 | 0 |
| K970188 | SEALITE SCIENCES, INC. AQUALITE PROLACTIN | Sealite Sciences, Inc. | 1997-02-20 | 34 | 0 |
| K964748 | ELECSYS PROLACTIN ASSAY | Boehringer Mannheim Corp. | 1997-01-21 | 56 | 0 |
| K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 | Diagnostic Systems Laboratories, Inc. | 1996-04-26 | 77 | 1 |
| K960060 | DSL ACTIVE PROLACTIN IRMA | Diagnostic Systems Laboratories, Inc. | 1996-02-29 | 56 | 0 |
| K954680 | ACCESS PROLACTIN ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1995-10-20 | 18 | 0 |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-10-03 | 77 | 0 |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-09-25 | 69 | 0 |
| K944698 | AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 | Organon Teknika Corp. | 1995-03-21 | 179 | 0 |
| K943811 | ENZYME-LINKED FLUORESCENT IMMUNOASSAY | Biomerieux Vitek, Inc. | 1994-11-02 | 89 | 0 |
| K935675 | AXSYM PROLACTIN | Abbott Laboratories | 1994-06-21 | 207 | 0 |
| K941220 | DUPONT ACA PLUS PROLACTIN (PROL) METHOD | Dupont Medical Products | 1994-06-03 | 81 | 0 |
| K941175 | ACCESS PROLACTIN | Bio-Rad Laboratories, Inc. | 1994-06-02 | 80 | 0 |
| K930305 | COBAS CORE PROLACTIN EIA | Roche Diagnostic Systems, Inc. | 1993-08-19 | 210 | 0 |
| K926386 | VISTA PROLACTIN ASSAY | Syva Co. | 1993-03-29 | 97 | 0 |
| K925846 | IMMULITE PROLACTIN | Diagnostic Products Corp. | 1993-03-05 | 107 | 0 |
| K922715 | IMMUCHEM PRL-MW ELISA | Icn Biomedicals, Inc. | 1992-10-05 | 122 | 0 |
| K922170 | AMERLITE PROLACTIN-30 ASSAY | Eastman Kodak Company | 1992-09-02 | 117 | 0 |
| K920921 | ELISA TUBE PROLACTIN TEST KIT | Bio Clinic Co. | 1992-04-08 | 40 | 0 |
| K920345 | PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) | Medix Biotech, Inc. | 1992-03-18 | 51 | 0 |
| K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 | Amersham Corp. | 1992-02-18 | 155 | 0 |
| K914107 | PROLACTIN IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-09-30 | 17 | 0 |
| K913280 | OPUS(R) PROLACTIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-08-16 | 23 | 0 |
| K904714 | CIBA CORNING ACS PROLACTIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1990-11-07 | 20 | 2 |
| K904483 | ELEGANCE PROLACTIN ELISA | Bioclone Australia Pty , Ltd. | 1990-11-05 | 34 | 0 |
| K904458 | LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION | London Diagnostics, Inc. | 1990-10-12 | 11 | 0 |
| K902698 | AFFINITY PROLACTIN TEST SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-07-19 | 30 | 0 |
| K901673 | PROLACTIN (LACTOGEN) TEST SYSTEM | Baxter Healthcare Corp | 1990-06-12 | 63 | 0 |
| K901578 | COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2 | Diagnostic Products Corp. | 1990-04-19 | 15 | 0 |
| K900695 | ENZYMUN TEST(R) PROLACTIN | Boehringer Mannheim Corp. | 1990-03-30 | 45 | 0 |
| K896162 | ABBOTT IMX PROLACTIN | Abbott Laboratories | 1990-01-19 | 87 | 0 |
| K896641 | MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1989-12-27 | 33 | 0 |
| K895380 | SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-10-17 | 48 | 0 |
| K894988 | CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1989-10-12 | 65 | 0 |
| K895003 | MILENIA(TM) PROLACTIN (MKPR1,5) | Diagnostic Products Corp. | 1989-09-18 | 41 | 0 |
| K883747 | IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES | Diagnostic Products Corp. | 1988-11-01 | 61 | 0 |
| K883878 | AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) | Amersham Corp. | 1988-11-01 | 49 | 0 |
| K883269 | PRL-QUANT | Leeco Diagnostics, Inc. | 1988-09-13 | 41 | 0 |
| K881774 | PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-06-08 | 43 | 0 |
| K880296 | LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY | London Diagnostics, Inc. | 1988-03-24 | 59 | 0 |
| K880218 | BINAX PROLACTIN IRMA DIAGNOSTIC KIT | Binax, Inc. | 1988-03-01 | 41 | 0 |
| K874621 | FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 | Cyberfluor, Inc. | 1988-01-11 | 62 | 0 |
| K873355 | MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT | Medix Biotech, Inc. | 1987-10-09 | 50 | 0 |
| K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA | Serono Diagnostics, Inc. | 1987-09-25 | 32 | 0 |
| K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS | Serono Diagnostics, Inc. | 1987-09-18 | 59 | 0 |
| K871542 | HPROLACTIN KIT | Immuchem Corp. | 1987-05-14 | 24 | 0 |
| K864439 | BECKMAN EPSILON(TM) PROLACTIN TEST KIT | Beckman Instruments, Inc. | 1987-01-21 | 70 | 0 |
| K864075 | UBI MAGIWEL(TM) PROLACTIN QUANTATIVE | United Biotech, Inc. | 1986-12-16 | 57 | 0 |
| K863860 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN | Hybritech, Inc. | 1986-11-21 | 49 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda