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.
Recent Cleared Devices (20 of 57)
Showing 20 most recent of 57 cleared devices.
| 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 |
Top Applicants
- Amersham Corp. — 4 clearances
- Diagnostic Products Corp. — 4 clearances
- Baxter Diagnostics, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances
- Biotecx Laboratories, Inc. — 2 clearances
