Panels › Clinical Chemistry › Product code CFT · Class 1
Radioimmunoassay, Prolactin (Lactogen)
Regulation 862.1625
0510(k)s in 12 months (80 all time)
0recalls in 12 months (6 all time)
4recalls that name a 510(k)
Top companies in CFT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 1997 | K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA Monobind | CFT |
| Feb 25, 1997 | K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS Johnson & Johnson Clinical Diagnostics, Inc. | CFT |
| Feb 20, 1997 | K970188 | SEALITE SCIENCES, INC. AQUALITE PROLACTIN Sealite Sciences, Inc. | CFT |
| Jan 21, 1997 | K964748 | ELECSYS PROLACTIN ASSAY Boehringer Mannheim Corp. | CFT |
| Apr 26, 1996 | K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 Diagnostic Systems Laboratories, Inc. | CFT |
| Feb 29, 1996 | K960060 | DSL ACTIVE PROLACTIN IRMA Diagnostic Systems Laboratories, Inc. | CFT |
| Oct 20, 1995 | K954680 | ACCESS PROLACTIN ASSAY (MODIFICATION) Bio-Rad Laboratories, Inc. | CFT |
| Oct 3, 1995 | K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) Abbott Mfg., Inc. | CFT |
| Sep 25, 1995 | K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) Abbott Mfg., Inc. | CFT |
| Mar 21, 1995 | K944698 | AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 Organon Teknika Corp. | CFT |
| Nov 2, 1994 | K943811 | ENZYME-LINKED FLUORESCENT IMMUNOASSAY Biomerieux Vitek, Inc. | CFT |
| Jun 21, 1994 | K935675 | AXSYM PROLACTIN Abbott Laboratories | CFT |
| Jun 3, 1994 | K941220 | DUPONT ACA PLUS PROLACTIN (PROL) METHOD Dupont Medical Products | CFT |
| Jun 2, 1994 | K941175 | ACCESS PROLACTIN Bio-Rad Laboratories, Inc. | CFT |
| Aug 19, 1993 | K930305 | COBAS CORE PROLACTIN EIA Roche Diagnostic Systems, Inc. | CFT |
| Mar 29, 1993 | K926386 | VISTA PROLACTIN ASSAY Syva Co. | CFT |
| Mar 5, 1993 | K925846 | IMMULITE PROLACTIN Diagnostic Products Corp. | CFT |
| Oct 5, 1992 | K922715 | IMMUCHEM PRL-MW ELISA Icn Biomedicals, Inc. | CFT |
| Sep 2, 1992 | K922170 | AMERLITE PROLACTIN-30 ASSAY Eastman Kodak Company | CFT |
| Apr 8, 1992 | K920921 | ELISA TUBE PROLACTIN TEST KIT Bio Clinic Co. | CFT |
| Mar 18, 1992 | K920345 | PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) Medix Biotech, Inc. | CFT |
| Feb 18, 1992 | K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 Amersham Corp. | CFT |
| Sep 30, 1991 | K914107 | PROLACTIN IRMA IMMUNOMAG Pantex, Div. Bio-Analysis, Inc. | CFT |
| Aug 16, 1991 | K913280 | OPUS(R) PROLACTIN TEST SYSTEM Pb Diagnostic Systems, Inc. | CFT |
| Nov 7, 1990 | K904714 | CIBA CORNING ACS PROLACTIN IMMUNOASSAY Ciba Corning Diagnostics Corp. | CFT |
| Nov 5, 1990 | K904483 | ELEGANCE PROLACTIN ELISA Bioclone Australia Pty , Ltd. | CFT |
| Oct 12, 1990 | K904458 | LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION London Diagnostics, Inc. | CFT |
| Jul 19, 1990 | K902698 | AFFINITY PROLACTIN TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | CFT |
| Jun 12, 1990 | K901673 | PROLACTIN (LACTOGEN) TEST SYSTEM Baxter Healthcare Corp | CFT |
| Apr 19, 1990 | K901578 | COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2 Diagnostic Products Corp. | CFT |
| Mar 30, 1990 | K900695 | ENZYMUN TEST(R) PROLACTIN Boehringer Mannheim Corp. | CFT |
| Jan 19, 1990 | K896162 | ABBOTT IMX PROLACTIN Abbott Laboratories | CFT |
| Dec 27, 1989 | K896641 | MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. | CFT |
| Oct 17, 1989 | K895380 | SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY Serono-Baker Diagnostics, Inc. | CFT |
| Oct 12, 1989 | K894988 | CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY Ciba Corning Diagnostics Corp. | CFT |
| Sep 18, 1989 | K895003 | MILENIA(TM) PROLACTIN (MKPR1,5) Diagnostic Products Corp. | CFT |
| Nov 1, 1988 | K883878 | AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) Amersham Corp. | CFT |
| Nov 1, 1988 | K883747 | IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES Diagnostic Products Corp. | CFT |
| Sep 13, 1988 | K883269 | PRL-QUANT Leeco Diagnostics, Inc. | CFT |
| Jun 8, 1988 | K881774 | PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | CFT |
| Mar 24, 1988 | K880296 | LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY London Diagnostics, Inc. | CFT |
| Mar 1, 1988 | K880218 | BINAX PROLACTIN IRMA DIAGNOSTIC KIT Binax, Inc. | CFT |
| Jan 11, 1988 | K874621 | FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 Cyberfluor, Inc., CA | CFT |
| Oct 9, 1987 | K873355 | MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT Medix Biotech, Inc. | CFT |
| Sep 25, 1987 | K873400 | PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA Serono Diagnostics, Inc. | CFT |
| Sep 18, 1987 | K872862 | PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS Serono Diagnostics, Inc. | CFT |
| May 14, 1987 | K871542 | HPROLACTIN KIT Immuchem Corp. | CFT |
| Jan 21, 1987 | K864439 | BECKMAN EPSILON(TM) PROLACTIN TEST KIT Beckman Instruments, Inc. | CFT |
| Dec 16, 1986 | K864075 | UBI MAGIWEL(TM) PROLACTIN QUANTATIVE United Biotech, Inc. | CFT |
| Nov 21, 1986 | K863860 | TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN Hybritech, Inc. | CFT |
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