Atlas FDA

JLS

57 FDA 510(k) clearances · Product code

46 daysmedian time to decision
126 days90th percentile
57clearances measured

FDA profile

Official device name
Radioimmunoassay, Progesterone
Device class
Class I (low risk)
Regulation
21 CFR 862.1620
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2012: 6 · 2013: 19 · 2021: 41 · 2022: 17 · 2023: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (K040923)Ibl GmbH2004-07-22
PROGESTERONE ELISA (K973898)Kmi Diagnostics, Inc.1997-11-13
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) (K972133)Johnson & Johnson Clinical Diagnostics, Inc.1997-06-24
OPUS PROGESTERONE (K971725)Behring Diagnostics, Inc.1997-06-18
ELECSYS PROGESTERONE ASSAY (K964841)Boehringer Mannheim Corp.1997-03-24
VIDAS PROESTERONE (PRG) (30 409) (K965084)bioMerieux, Inc.1997-01-09
AXSYM PROGESTERONE (K955025)Abbott Laboratories1996-03-07
ACCESS PROGESTERONE ASSAY (K955769)Bio-Rad Laboratories, Inc.1996-02-05
PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (K952075)Bayer Corp.1995-06-13
AURAFLEX PROGESTERONE 150TEST PACK (K951630)Organon Teknika Corp.1995-05-08
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (K950570)Baxter Diagnostics, Inc.1995-04-11
IMMULITE PROGESTERONE (K944211)Diagnostic Products Corp.1994-12-19
IMMULITE PROGESTERONE (K935138)Diagnostic Products Corp.1994-01-11
SYNELISA PROGESTERONE (K933128)Elias U.S.A., Inc.1993-11-05
AIA-PACK(R) PROG ASSAY (K933269)Tosoh Medics, Inc.1993-10-22
PROGESTERONE RADIOIMMUNOASSAY KIT (K931228)Immunotech Corp.1993-10-22
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY (K933635)Baxter Diagnostics, Inc.1993-10-08
CIBA CORNING ACS PROGESTERONE IMMUNOASSAY (K932955)Ciba Corning Diagnostics Corp.1993-08-02
FIAGEN PROGESTERONE (K923410)Cyberfluor, Inc.1992-12-03
AFFINITY PRG (K920230)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-18
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (K914462)Serono-Baker Diagnostics, Inc.1991-10-23
MILENIA PROGESTERONE (K911512)Diagnostic Products Corp.1991-05-22
ENZYMUN-TEST PROGESTERONE (K910683)Boehringer Mannheim Corp.1991-04-08
IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT (K894049)Pantex, Div. Bio-Analysis, Inc.1989-09-08
RIA-GNOST PROGESTERONE (K890836)Cambridge Medical Technology1989-03-16
DELFIA PROGESTERONE KIT (K890428)Pharmacia, Inc.1989-02-23
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY (K884794)Serono-Baker Diagnostics, Inc.1989-02-02
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 (K884100)Amersham Corp.1988-11-10
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT (K880934)Amersham Corp.1988-04-18
PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (K873431)Serono Diagnostics, Inc.1987-10-20
PROGESTERONE CLASP RADIOIMMUNOASSAY KIT (K871211)Biotecx Laboratories, Inc.1987-04-13
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT (K864855)Amersham Corp.1987-02-25
PROGESTERONE SYSTEM BY EIA (K864156)Intl. Bioclinical, Inc.1986-11-24
RAMP PROGESTURINE PDG ASSAY--48 TEST KIT (K860924)Monoclonal Antibodies, Inc.1986-07-02
IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS (K854094)Immuchem Corp.1986-02-28
DSL ANDROSTENEDIONE RIA (DSL #4200) (K854675)Diagnostic Systems Laboratories, Inc.1986-01-28
DSL PROGESTERONE RIA (DSL #3400) (K854649)Diagnostic Systems Laboratories, Inc.1985-12-13
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT (K850056)Leeco Diagnostics, Inc.1985-02-06
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE (K845026)Amersham Corp.1985-02-01
PROGESTERONE DIRECT RIA KIT-RADIOIMM (K841333)Biotecx Laboratories, Inc.1984-05-02
HYDROXYPROGESTERONE BY RIA 17A (K840886)Radioassay Systems Laboratories, Inc.1984-04-18
DIRIA-PROGK IMMUNOASSAY (K832694)Sorin Biomedica, Fiat, USA, Inc.1984-01-11
HYDROXYPROGESTERONE-17 (K832297)Diagnostics Biochem Canada, Inc.1983-09-01
IMMO PHASE DIRECT PROGESTERONE RADIO- (K830880)Corning Medical & Scientific1983-04-18
LIQUISOL PROGESTERONE RADIOIMMUNO (K820686)Damon Corp.1982-04-01
COAT-A-COUNT PROGESTERONE KIA KIT (K820534)Diagnostic Products Corp.1982-03-16
PROGESTERONE KIT BY RIA (K813484)Immuchem Corp.1981-12-22
PROGESTERONE DIRECT RIA KIT (125I) (K811907)Immunalysis Corporation1981-07-23
NATAL-TEC PROGESTERONE (K811369)Armkel, LLC1981-05-29
PROGESTERONE KIT (K810804)Cambridge Nuclear Corp.1981-04-01
NORDICLAB PROGESTERONE RIA TEST (K800922)Nordiclab Intl.1980-05-14
RSL (125 L) PROGESTERONE KIT (K800126)Radioassay Systems Laboratories, Inc.1980-02-13
PROGESTERONE RADIOIMMUNOASSAY KIT (K791051)Cis Radiopharmaceuticals, Inc.1979-07-24
RIA OF PROGESTERONE (K790911)Calbiochem-Behring Corp.1979-06-27
PROGESTERONE (K790440)Serono Laboratories, Inc.1979-05-03
RIA KIT, PROGESTERONE (K782009)The Upjohn Co.1979-03-02
REAGENT SYSTEM, PROGESTERONE, ARIA (K770732)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-06-22

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