JLS · Radioimmunoassay, Progesterone
Clinical Chemistry · 21 CFR 862.1620 · Class 1
Overview
| Product Code | JLS |
|---|---|
| Device Name | Radioimmunoassay, Progesterone |
| Regulation | 21 CFR 862.1620 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (57)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040923 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA | Ibl GmbH | Jul 22, 2004 | SESE |
| K973898 | PROGESTERONE ELISA | Kmi Diagnostics, Inc. | Nov 13, 1997 | SESE |
| K972133 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) | Johnson & Johnson Clinical Diagnostics, Inc. | Jun 24, 1997 | SESE |
| K971725 | OPUS PROGESTERONE | Behring Diagnostics, Inc. | Jun 18, 1997 | SESE |
| K964841 | ELECSYS PROGESTERONE ASSAY | Boehringer Mannheim Corp. | Mar 24, 1997 | SESE |
| K965084 | VIDAS PROESTERONE (PRG) (30 409) | bioMerieux, Inc. | Jan 9, 1997 | SESE |
| K955025 | AXSYM PROGESTERONE | Abbott Laboratories | Mar 7, 1996 | SESE |
| K955769 | ACCESS PROGESTERONE ASSAY | Bio-Rad Laboratories, Inc. | Feb 5, 1996 | SESE |
| K952075 | PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM | Bayer Corp. | Jun 13, 1995 | SESE |
| K951630 | AURAFLEX PROGESTERONE 150TEST PACK | Organon Teknika Corp. | May 8, 1995 | SESE |
| K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | Apr 11, 1995 | SESE |
| K944211 | IMMULITE PROGESTERONE | Diagnostic Products Corp. | Dec 19, 1994 | SESE |
| K935138 | IMMULITE PROGESTERONE | Diagnostic Products Corp. | Jan 11, 1994 | SESE |
| K933128 | SYNELISA PROGESTERONE | Elias U.S.A., Inc. | Nov 5, 1993 | SESE |
| K933269 | AIA-PACK(R) PROG ASSAY | Tosoh Medics, Inc. | Oct 22, 1993 | SESE |
| K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT | Immunotech Corp. | Oct 22, 1993 | SESE |
| K933635 | STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY | Baxter Diagnostics, Inc. | Oct 8, 1993 | SESE |
| K932955 | CIBA CORNING ACS PROGESTERONE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Aug 2, 1993 | SESE |
| K923410 | FIAGEN PROGESTERONE | Cyberfluor, Inc. | Dec 3, 1992 | SESE |
| K920230 | AFFINITY PRG | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 18, 1992 | SESE |
| K914462 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) | Serono-Baker Diagnostics, Inc. | Oct 23, 1991 | SESE |
| K911512 | MILENIA PROGESTERONE | Diagnostic Products Corp. | May 22, 1991 | SESE |
| K910683 | ENZYMUN-TEST PROGESTERONE | Boehringer Mannheim Corp. | Apr 8, 1991 | SESE |
| K894049 | IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | Sep 8, 1989 | SESE |
| K890836 | RIA-GNOST PROGESTERONE | Cambridge Medical Technology | Mar 16, 1989 | SESE |
| K890428 | DELFIA PROGESTERONE KIT | Pharmacia, Inc. | Feb 23, 1989 | SESE |
| K884794 | PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | Feb 2, 1989 | SESE |
| K884100 | AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 | Amersham Corp. | Nov 10, 1988 | SESE |
| K880934 | MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT | Amersham Corp. | Apr 18, 1988 | SESE |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | Serono Diagnostics, Inc. | Oct 20, 1987 | SESE |
| K871211 | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT | Biotecx Laboratories, Inc. | Apr 13, 1987 | SESE |
| K864855 | AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT | Amersham Corp. | Feb 25, 1987 | SESE |
| K864156 | PROGESTERONE SYSTEM BY EIA | Intl. Bioclinical, Inc. | Nov 24, 1986 | SESE |
| K860924 | RAMP PROGESTURINE PDG ASSAY--48 TEST KIT | Monoclonal Antibodies, Inc. | Jul 2, 1986 | SESE |
| K854094 | IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS | Immuchem Corp. | Feb 28, 1986 | SESE |
| K854675 | DSL ANDROSTENEDIONE RIA (DSL #4200) | Diagnostic Systems Laboratories, Inc. | Jan 28, 1986 | SESE |
| K854649 | DSL PROGESTERONE RIA (DSL #3400) | Diagnostic Systems Laboratories, Inc. | Dec 13, 1985 | SESE |
| K850056 | LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT | Leeco Diagnostics, Inc. | Feb 6, 1985 | SESE |
| K845026 | AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE | Amersham Corp. | Feb 1, 1985 | SESE |
| K841333 | PROGESTERONE DIRECT RIA KIT-RADIOIMM | Biotecx Laboratories, Inc. | May 2, 1984 | SESE |
| K840886 | HYDROXYPROGESTERONE BY RIA 17A | Radioassay Systems Laboratories, Inc. | Apr 18, 1984 | SESE |
| K832694 | DIRIA-PROGK IMMUNOASSAY | Sorin Biomedica, Fiat, USA, Inc. | Jan 11, 1984 | SESE |
| K832297 | HYDROXYPROGESTERONE-17 | Diagnostics Biochem Canada, Inc. | Sep 1, 1983 | SESE |
| K830880 | IMMO PHASE DIRECT PROGESTERONE RADIO- | Corning Medical & Scientific | Apr 18, 1983 | SESE |
| K820686 | LIQUISOL PROGESTERONE RADIOIMMUNO | Damon Corp. | Apr 1, 1982 | SESE |
| K820534 | COAT-A-COUNT PROGESTERONE KIA KIT | Diagnostic Products Corp. | Mar 16, 1982 | SESE |
| K813484 | PROGESTERONE KIT BY RIA | Immuchem Corp. | Dec 22, 1981 | SESE |
| K811907 | PROGESTERONE DIRECT RIA KIT (125I) | Immunalysis Corporation | Jul 23, 1981 | SESE |
| K811369 | NATAL-TEC PROGESTERONE | Armkel, LLC | May 29, 1981 | SESE |
| K810804 | PROGESTERONE KIT | Cambridge Nuclear Corp. | Apr 1, 1981 | SESE |
| K800922 | NORDICLAB PROGESTERONE RIA TEST | Nordiclab Intl. | May 14, 1980 | SESE |
| K800126 | RSL (125 L) PROGESTERONE KIT | Radioassay Systems Laboratories, Inc. | Feb 13, 1980 | SESE |
| K791051 | PROGESTERONE RADIOIMMUNOASSAY KIT | Cis Radiopharmaceuticals, Inc. | Jul 24, 1979 | SESE |
| K790911 | RIA OF PROGESTERONE | Calbiochem-Behring Corp. | Jun 27, 1979 | SESE |
| K790440 | PROGESTERONE | Serono Laboratories, Inc. | May 3, 1979 | SESE |
| K782009 | RIA KIT, PROGESTERONE | The Upjohn Co. | Mar 2, 1979 | SESE |
| K770732 | REAGENT SYSTEM, PROGESTERONE, ARIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 22, 1977 | SESE |
Top Applicants
- Diagnostic Products Corp. — 4 clearances
- Amersham Corp. — 4 clearances
- Serono-Baker Diagnostics, Inc. — 2 clearances
- Radioassay Systems Laboratories, Inc. — 2 clearances
- Immuchem Corp. — 2 clearances
