Atlas FDA

CFT

80 FDA 510(k) clearances · Product code

49 daysmedian time to decision
107 days90th percentile
80clearances measured

FDA profile

Official device name
Radioimmunoassay, Prolactin (Lactogen)
Device class
Class I (low risk)
Regulation
21 CFR 862.1625
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2021: 23 · 2022: 29 · 2023: 27 · 2024: 25 · 2025: 23 · 2026: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PROLACTIN (PRL) HORMONE MICROPLATE ELISA (K971921)Monobind1997-06-24
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (K970281)Johnson & Johnson Clinical Diagnostics, Inc.1997-02-25
SEALITE SCIENCES, INC. AQUALITE PROLACTIN (K970188)Sealite Sciences, Inc.1997-02-20
ELECSYS PROLACTIN ASSAY (K964748)Boehringer Mannheim Corp.1997-01-21
DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (K960561)Diagnostic Systems Laboratories, Inc.1996-04-26
DSL ACTIVE PROLACTIN IRMA (K960060)Diagnostic Systems Laboratories, Inc.1996-02-29
ACCESS PROLACTIN ASSAY (MODIFICATION) (K954680)Bio-Rad Laboratories, Inc.1995-10-20
ABBOTT IMX PROLACTIN(MODIFICATION) (K953656)Abbott Mfg., Inc.1995-10-03
ABBOTT AXSYM PROLACTIN(MODIFICATION) (K953657)Abbott Mfg., Inc.1995-09-25
AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (K944698)Organon Teknika Corp.1995-03-21
ENZYME-LINKED FLUORESCENT IMMUNOASSAY (K943811)Biomerieux Vitek, Inc.1994-11-02
AXSYM PROLACTIN (K935675)Abbott Laboratories1994-06-21
DUPONT ACA PLUS PROLACTIN (PROL) METHOD (K941220)Dupont Medical Products1994-06-03
ACCESS PROLACTIN (K941175)Bio-Rad Laboratories, Inc.1994-06-02
COBAS CORE PROLACTIN EIA (K930305)Roche Diagnostic Systems, Inc.1993-08-19
VISTA PROLACTIN ASSAY (K926386)Syva Co.1993-03-29
IMMULITE PROLACTIN (K925846)Diagnostic Products Corp.1993-03-05
IMMUCHEM PRL-MW ELISA (K922715)Icn Biomedicals, Inc.1992-10-05
AMERLITE PROLACTIN-30 ASSAY (K922170)Eastman Kodak Company1992-09-02
ELISA TUBE PROLACTIN TEST KIT (K920921)Bio Clinic Co.1992-04-08
PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) (K920345)Medix Biotech, Inc.1992-03-18
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 (K914135)Amersham Corp.1992-02-18
PROLACTIN IRMA IMMUNOMAG (K914107)Pantex, Div. Bio-Analysis, Inc.1991-09-30
OPUS(R) PROLACTIN TEST SYSTEM (K913280)Pb Diagnostic Systems, Inc.1991-08-16
CIBA CORNING ACS PROLACTIN IMMUNOASSAY (K904714)Ciba Corning Diagnostics Corp.1990-11-07
ELEGANCE PROLACTIN ELISA (K904483)Bioclone Australia Pty , Ltd.1990-11-05
LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION (K904458)London Diagnostics, Inc.1990-10-12
AFFINITY PROLACTIN TEST SYSTEM (K902698)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-07-19
PROLACTIN (LACTOGEN) TEST SYSTEM (K901673)Baxter Healthcare Corp1990-06-12
COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2 (K901578)Diagnostic Products Corp.1990-04-19
ENZYMUN TEST(R) PROLACTIN (K900695)Boehringer Mannheim Corp.1990-03-30
ABBOTT IMX PROLACTIN (K896162)Abbott Laboratories1990-01-19
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT (K896641)Medix Biotech, Inc.1989-12-27
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY (K895380)Serono-Baker Diagnostics, Inc.1989-10-17
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY (K894988)Ciba Corning Diagnostics Corp.1989-10-12
MILENIA(TM) PROLACTIN (MKPR1,5) (K895003)Diagnostic Products Corp.1989-09-18
IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES (K883747)Diagnostic Products Corp.1988-11-01
AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) (K883878)Amersham Corp.1988-11-01
PRL-QUANT (K883269)Leeco Diagnostics, Inc.1988-09-13
PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM (K881774)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-06-08
LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY (K880296)London Diagnostics, Inc.1988-03-24
BINAX PROLACTIN IRMA DIAGNOSTIC KIT (K880218)Binax, Inc.1988-03-01
FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 (K874621)Cyberfluor, Inc.1988-01-11
MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT (K873355)Medix Biotech, Inc.1987-10-09
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (K873400)Serono Diagnostics, Inc.1987-09-25
PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS (K872862)Serono Diagnostics, Inc.1987-09-18
HPROLACTIN KIT (K871542)Immuchem Corp.1987-05-14
BECKMAN EPSILON(TM) PROLACTIN TEST KIT (K864439)Beckman Instruments, Inc.1987-01-21
UBI MAGIWEL(TM) PROLACTIN QUANTATIVE (K864075)United Biotech, Inc.1986-12-16
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN (K863860)Hybritech, Inc.1986-11-21
PROLACTIN RIABEAD II DIAGNOSTIC KIT (K863240)Abbott Laboratories1986-09-29
ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT (K860823)Cis-Us, Inc.1986-08-19
SUCROSEP HUMAN PROLACTIN (HPR) IRMA (K861271)Boots-Celltech Diagnostics, Inc.1986-06-27
DELFIA (TM) HUMAN PROLACTIN (K861542)Lkb Instruments, Inc.1986-06-17
LEE-BEAD PROLACTIN (EIA) (K861945)Leeco Diagnostics, Inc.1986-06-13
ENCORE PROLACTIN REAGENT (K860221)Hybritech, Inc.1986-03-05
ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM (K854805)Nichols Institute Diagnostics1986-01-28
TERUMO SENSIBEAD EIA HPRL KIT (K854768)Terumo Medical Corp.1986-01-13
PROLACTIN SYSTEM BY RIA (K851330)American Bioclinical, Inc.1985-04-29
PRL QUIK RIA KIT (K850383)Pacific Biotech, Inc.1985-03-01
TANDEM - EPRL (K843804)Hybritech, Inc.1984-11-13
PROLACTIN IRMA (K842478)Euro-Diagnostics BV1984-09-14
PROLACTIN RIABEAD PROLACTIN RADIOIMM (K841118)Abbott Laboratories1984-05-11
COAT-A-COUNT NHS-PROLACTIN KIT AND (K833925)Diagnostic Products Corp.1984-01-24
RIANEN PROLACTIN 125I KIT (K831345)New England Nuclear1983-06-08
RADIOIMMUNOASSAY TEST SYSTEM PRL (K830412)Monobind1983-04-05
RIASET PROLACTIN RIA KIT (K823304)Immulok, Inc.1982-12-22
ABBOTT LABORATORIES PROLACTIN EIA (K822759)Abbott Laboratories1982-10-21
TANDEM PROLACTIN KIT (K821545)Hybritech, Inc.1982-06-11
PROLACTIN (125-I) RADIOIMMUNOASSAY KIT (K821305)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-05-24
CENTRIA PROLACTIN TEST SET (K813572)Ventrex Laboratories, Inc.1982-03-26
LEECO PRL-QUANT DIAGNOSTIC TEST KIT (K820039)Leeco Diagnostics, Inc.1982-01-22
MARRIA-HPRL RIA KIT (K812112)Intl. Immunoassay Laboratories, Inc.1981-08-13
MRI PROLACTIN RIA KIT (K810949)Microanalytic Research, Inc.1981-07-10
PROLACTIN (125) RADIOIMMUNAOASSAY (K803273)Corning Medical & Scientific1981-01-16
LACTI-QUANT (K801849)Nuclear Medical Laboratories, Inc.1980-09-16
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- (K801020)Travenol Laboratories, S.A.1980-07-08
PROLACTIN RIA KIT (K800740)Amersham Corp.1980-04-16
125 I PROLACTIN HORMONE RIA KIT (K792166)Diagnostic Products Corp.1979-11-13
RIA KIT, PROLACTIN (K790003)Cis Radiopharmaceuticals, Inc.1979-03-12

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Every clearance here is in the API, with alerts when new ones post.