Product Code: JLS FDA class 1 21 CFR 862.1620

Radioimmunoassay, Progesterone

Clinical Chemistry

This device is a radioimmunoassay system used to measure progesterone levels in patient serum or plasma, used in assessing ovarian function, confirming ovulation, monitoring luteal phase adequacy, and evaluating early pregnancy or infertility. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket submission. The product code is JLS, regulated under 21 CFR 862.1620, within the Clinical Chemistry medical specialty.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code JLS in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: JLS
Device Class: FDA class 1
Regulation Number: 862.1620
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K040923	LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA	Jul 22, 2004	Substantially Equivalent	Ibl GmbH
K973898	PROGESTERONE ELISA	Nov 13, 1997	Substantially Equivalent	Kmi Diagnostics, Inc.
K972133	VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)	Jun 24, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K971725	OPUS PROGESTERONE	Jun 18, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K964841	ELECSYS PROGESTERONE ASSAY	Mar 24, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K965084	VIDAS PROESTERONE (PRG) (30 409)	Jan 09, 1997	Substantially Equivalent	bioMerieux, Inc.
K955025	AXSYM PROGESTERONE	Mar 07, 1996	Substantially Equivalent	Abbott Laboratories
K955769	ACCESS PROGESTERONE ASSAY	Feb 05, 1996	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K952075	PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM	Jun 13, 1995	Substantially Equivalent	Bayer Corp.
K951630	AURAFLEX PROGESTERONE 150TEST PACK	May 08, 1995	Substantially Equivalent	Organon Teknika Corp.
K950570	STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY	Apr 11, 1995	Substantially Equivalent	Baxter Diagnostics, Inc.
K944211	IMMULITE PROGESTERONE	Dec 19, 1994	Substantially Equivalent	Diagnostic Products Corp.
K935138	IMMULITE PROGESTERONE	Jan 11, 1994	Substantially Equivalent	Diagnostic Products Corp.
K933128	SYNELISA PROGESTERONE	Nov 05, 1993	Substantially Equivalent	Elias U.S.A., Inc.
K933269	AIA-PACK(R) PROG ASSAY	Oct 22, 1993	Substantially Equivalent	Tosoh Medics, Inc.
K931228	PROGESTERONE RADIOIMMUNOASSAY KIT	Oct 22, 1993	Substantially Equivalent	Immunotech Corp.
K933635	STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY	Oct 08, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K932955	CIBA CORNING ACS PROGESTERONE IMMUNOASSAY	Aug 02, 1993	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K923410	FIAGEN PROGESTERONE	Dec 03, 1992	Substantially Equivalent	Cyberfluor, Inc.
K920230	AFFINITY PRG	Feb 18, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K914462	SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)	Oct 23, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K911512	MILENIA PROGESTERONE	May 22, 1991	Substantially Equivalent	Diagnostic Products Corp.
K910683	ENZYMUN-TEST PROGESTERONE	Apr 08, 1991	Substantially Equivalent	Boehringer Mannheim Corp.
K894049	IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT	Sep 08, 1989	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K890836	RIA-GNOST PROGESTERONE	Mar 16, 1989	Substantially Equivalent	Cambridge Medical Technology
K890428	DELFIA PROGESTERONE KIT	Feb 23, 1989	Substantially Equivalent	Pharmacia, Inc.
K884794	PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY	Feb 02, 1989	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K884100	AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144	Nov 10, 1988	Substantially Equivalent	Amersham Corp.
K880934	MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT	Apr 18, 1988	Substantially Equivalent	Amersham Corp.
K873431	PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH	Oct 20, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K871211	PROGESTERONE CLASP RADIOIMMUNOASSAY KIT	Apr 13, 1987	Substantially Equivalent	Biotecx Laboratories, Inc.
K864855	AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT	Feb 25, 1987	Substantially Equivalent	Amersham Corp.
K864156	PROGESTERONE SYSTEM BY EIA	Nov 24, 1986	Substantially Equivalent	Intl. Bioclinical, Inc.
K860924	RAMP PROGESTURINE PDG ASSAY--48 TEST KIT	Jul 02, 1986	Substantially Equivalent	Monoclonal Antibodies, Inc.
K854094	IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS	Feb 28, 1986	Substantially Equivalent	Immuchem Corp.
K854675	DSL ANDROSTENEDIONE RIA (DSL #4200)	Jan 28, 1986	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K854649	DSL PROGESTERONE RIA (DSL #3400)	Dec 13, 1985	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K850056	LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT	Feb 06, 1985	Substantially Equivalent	Leeco Diagnostics, Inc.
K845026	AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE	Feb 01, 1985	Substantially Equivalent	Amersham Corp.
K841333	PROGESTERONE DIRECT RIA KIT-RADIOIMM	May 02, 1984	Substantially Equivalent	Biotecx Laboratories, Inc.
K840886	HYDROXYPROGESTERONE BY RIA 17A	Apr 18, 1984	Substantially Equivalent	Radioassay Systems Laboratories, Inc.
K832694	DIRIA-PROGK IMMUNOASSAY	Jan 11, 1984	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K832297	HYDROXYPROGESTERONE-17	Sep 01, 1983	Substantially Equivalent	Diagnostics Biochem Canada, Inc.
K830880	IMMO PHASE DIRECT PROGESTERONE RADIO-	Apr 18, 1983	Substantially Equivalent	Corning Medical & Scientific
K820686	LIQUISOL PROGESTERONE RADIOIMMUNO	Apr 01, 1982	Substantially Equivalent	Damon Corp.
K820534	COAT-A-COUNT PROGESTERONE KIA KIT	Mar 16, 1982	Substantially Equivalent	Diagnostic Products Corp.
K813484	PROGESTERONE KIT BY RIA	Dec 22, 1981	Substantially Equivalent	Immuchem Corp.
K811907	PROGESTERONE DIRECT RIA KIT (125I)	Jul 23, 1981	Substantially Equivalent	Immunalysis Corporation
K811369	NATAL-TEC PROGESTERONE	May 29, 1981	Substantially Equivalent	Armkel, LLC
K810804	PROGESTERONE KIT	Apr 01, 1981	Substantially Equivalent	Cambridge Nuclear Corp.
K800922	NORDICLAB PROGESTERONE RIA TEST	May 14, 1980	Substantially Equivalent	Nordiclab Intl.
K800126	RSL (125 L) PROGESTERONE KIT	Feb 13, 1980	Substantially Equivalent	Radioassay Systems Laboratories, Inc.
K791051	PROGESTERONE RADIOIMMUNOASSAY KIT	Jul 24, 1979	Substantially Equivalent	Cis Radiopharmaceuticals, Inc.
K790911	RIA OF PROGESTERONE	Jun 27, 1979	Substantially Equivalent	Calbiochem-Behring Corp.
K790440	PROGESTERONE	May 03, 1979	Substantially Equivalent	Serono Laboratories, Inc.
K782009	RIA KIT, PROGESTERONE	Mar 02, 1979	Substantially Equivalent	The Upjohn Co.
K770732	REAGENT SYSTEM, PROGESTERONE, ARIA	Jun 22, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic