FDA Product Code
FDA Product Code JLS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1620
510(k) Clearances — 57 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040923 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA | Ibl GmbH | 2004-07-22 | Traditional | PDF ↗ |
| K973898 | PROGESTERONE ELISA | Kmi Diagnostics, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K972133 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K971725 | OPUS PROGESTERONE | Behring Diagnostics, Inc. | 1997-06-18 | Traditional | PDF ↗ |
| K964841 | ELECSYS PROGESTERONE ASSAY | Boehringer Mannheim Corp. | 1997-03-24 | Traditional | PDF ↗ |
| K965084 | VIDAS PROESTERONE (PRG) (30 409) | bioMerieux, Inc. | 1997-01-09 | Traditional | PDF ↗ |
| K955025 | AXSYM PROGESTERONE | Abbott Laboratories | 1996-03-07 | Traditional | PDF ↗ |
| K955769 | ACCESS PROGESTERONE ASSAY | Bio-Rad Laboratories, Inc. | 1996-02-05 | Traditional | PDF ↗ |
| K952075 | PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM | Bayer Corp. | 1995-06-13 | Traditional | PDF ↗ |
| K951630 | AURAFLEX PROGESTERONE 150TEST PACK | Organon Teknika Corp. | 1995-05-08 | Traditional | PDF ↗ |
| K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1995-04-11 | Traditional | PDF ↗ |
| K944211 | IMMULITE PROGESTERONE | Diagnostic Products Corp. | 1994-12-19 | Traditional | PDF ↗ |
| K935138 | IMMULITE PROGESTERONE | Diagnostic Products Corp. | 1994-01-11 | Traditional | PDF ↗ |
| K933128 | SYNELISA PROGESTERONE | Elias U.S.A., Inc. | 1993-11-05 | Traditional | PDF ↗ |
| K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT | Immunotech Corp. | 1993-10-22 | Traditional | PDF ↗ |
| K933269 | AIA-PACK(R) PROG ASSAY | Tosoh Medics, Inc. | 1993-10-22 | Traditional | PDF ↗ |
| K933635 | STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY | Baxter Diagnostics, Inc. | 1993-10-08 | Traditional | PDF ↗ |
| K932955 | CIBA CORNING ACS PROGESTERONE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-08-02 | Traditional | PDF ↗ |
| K923410 | FIAGEN PROGESTERONE | Cyberfluor, Inc. | 1992-12-03 | Traditional | PDF ↗ |
| K920230 | AFFINITY PRG | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-02-18 | Traditional | PDF ↗ |
| K914462 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) | Serono-Baker Diagnostics, Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K911512 | MILENIA PROGESTERONE | Diagnostic Products Corp. | 1991-05-22 | Traditional | PDF ↗ |
| K910683 | ENZYMUN-TEST PROGESTERONE | Boehringer Mannheim Corp. | 1991-04-08 | Traditional | PDF ↗ |
| K894049 | IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1989-09-08 | Traditional | PDF ↗ |
| K890836 | RIA-GNOST PROGESTERONE | Cambridge Medical Technology | 1989-03-16 | Traditional | PDF ↗ |
| K890428 | DELFIA PROGESTERONE KIT | Pharmacia, Inc. | 1989-02-23 | Traditional | PDF ↗ |
| K884794 | PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-02-02 | Traditional | PDF ↗ |
| K884100 | AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 | Amersham Corp. | 1988-11-10 | Traditional | PDF ↗ |
| K880934 | MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT | Amersham Corp. | 1988-04-18 | Traditional | PDF ↗ |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | Serono Diagnostics, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K871211 | PROGESTERONE CLASP RADIOIMMUNOASSAY KIT | Biotecx Laboratories, Inc. | 1987-04-13 | Traditional | PDF ↗ |
| K864855 | AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT | Amersham Corp. | 1987-02-25 | Traditional | PDF ↗ |
| K864156 | PROGESTERONE SYSTEM BY EIA | Intl. Bioclinical, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K860924 | RAMP PROGESTURINE PDG ASSAY--48 TEST KIT | Monoclonal Antibodies, Inc. | 1986-07-02 | Traditional | PDF ↗ |
| K854094 | IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS | Immuchem Corp. | 1986-02-28 | Traditional | PDF ↗ |
| K854675 | DSL ANDROSTENEDIONE RIA (DSL #4200) | Diagnostic Systems Laboratories, Inc. | 1986-01-28 | Traditional | PDF ↗ |
| K854649 | DSL PROGESTERONE RIA (DSL #3400) | Diagnostic Systems Laboratories, Inc. | 1985-12-13 | Traditional | PDF ↗ |
| K850056 | LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT | Leeco Diagnostics, Inc. | 1985-02-06 | Traditional | PDF ↗ |
| K845026 | AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE | Amersham Corp. | 1985-02-01 | Traditional | PDF ↗ |
| K841333 | PROGESTERONE DIRECT RIA KIT-RADIOIMM | Biotecx Laboratories, Inc. | 1984-05-02 | Traditional | PDF ↗ |
| K840886 | HYDROXYPROGESTERONE BY RIA 17A | Radioassay Systems Laboratories, Inc. | 1984-04-18 | Traditional | PDF ↗ |
| K832694 | DIRIA-PROGK IMMUNOASSAY | Sorin Biomedica, Fiat, USA, Inc. | 1984-01-11 | Traditional | PDF ↗ |
| K832297 | HYDROXYPROGESTERONE-17 | Diagnostics Biochem Canada, Inc. | 1983-09-01 | Traditional | PDF ↗ |
| K830880 | IMMO PHASE DIRECT PROGESTERONE RADIO- | Corning Medical & Scientific | 1983-04-18 | Traditional | PDF ↗ |
| K820686 | LIQUISOL PROGESTERONE RADIOIMMUNO | Damon Corp. | 1982-04-01 | Traditional | PDF ↗ |
| K820534 | COAT-A-COUNT PROGESTERONE KIA KIT | Diagnostic Products Corp. | 1982-03-16 | Traditional | PDF ↗ |
| K813484 | PROGESTERONE KIT BY RIA | Immuchem Corp. | 1981-12-22 | Traditional | PDF ↗ |
| K811907 | PROGESTERONE DIRECT RIA KIT (125I) | Immunalysis Corporation | 1981-07-23 | Traditional | PDF ↗ |
| K811369 | NATAL-TEC PROGESTERONE | Armkel, LLC | 1981-05-29 | Traditional | PDF ↗ |
| K810804 | PROGESTERONE KIT | Cambridge Nuclear Corp. | 1981-04-01 | Traditional | PDF ↗ |
| K800922 | NORDICLAB PROGESTERONE RIA TEST | Nordiclab Intl. | 1980-05-14 | Traditional | PDF ↗ |
| K800126 | RSL (125 L) PROGESTERONE KIT | Radioassay Systems Laboratories, Inc. | 1980-02-13 | Traditional | PDF ↗ |
| K791051 | PROGESTERONE RADIOIMMUNOASSAY KIT | Cis Radiopharmaceuticals, Inc. | 1979-07-24 | Traditional | PDF ↗ |
| K790911 | RIA OF PROGESTERONE | Calbiochem-Behring Corp. | 1979-06-27 | Traditional | PDF ↗ |
| K790440 | PROGESTERONE | Serono Laboratories, Inc. | 1979-05-03 | Traditional | PDF ↗ |
| K782009 | RIA KIT, PROGESTERONE | The Upjohn Co. | 1979-03-02 | Traditional | PDF ↗ |
| K770732 | REAGENT SYSTEM, PROGESTERONE, ARIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-06-22 | Traditional | PDF ↗ |
Product code JLS · Class I · Clinical Chemistry. Data: openFDA.