510(k) K965084
- Device
- VIDAS PROESTERONE (PRG) (30 409)
- Applicant
- BIOMERIEUX, INC.
- 510(k) number
- K965084
- Product code
- JLS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-01-09
- Date received
- 1996-12-19
- Regulation
- 862.1620
- Classification name
- Radioimmunoassay, Progesterone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERRY MCGOVERN
- Address
- 1022 Hingham St. Rockland MA US 02370 02370
FDA Registration Numbers#
- 3017019647
- 3009335633
- 8010132
- 3005094123
- 3006198300
- 3003760091
- 3009984016
- 3002800697
- 3003559191
- 3017894300
- 2245285
- 3005333358
- 2432235
- 3022178699
- 2250051
- 3002809144
- 2182595
- 9612316
- 3007118747
- 3009491259
- 2020726
- 1222302
- 1036362
- 2517506
- 2419955
- 2122870
- 8031673
- 1827821
- 3011989923
- 2032682
- 3033967997
- 2133982
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 2029372
- 9710337
- 3005542422
- 1319681
- 8021924
- 3017379203
- 3002806944
- 8020790
- 2032839
- 3004192065
Source Documents#
Other 510(k) Records For Product Code JLS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040923 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA | Ibl GmbH | 2004-07-22 |
| K973898 | PROGESTERONE ELISA | Kmi Diagnostics, Inc. | 1997-11-13 |
| K972133 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-06-24 |
| K971725 | OPUS PROGESTERONE | Behring Diagnostics, Inc. | 1997-06-18 |
| K964841 | ELECSYS PROGESTERONE ASSAY | Boehringer Mannheim Corp. | 1997-03-24 |
| K955025 | AXSYM PROGESTERONE | Abbott Laboratories | 1996-03-07 |
| K955769 | ACCESS PROGESTERONE ASSAY | Bio-Rad Laboratories, Inc. | 1996-02-05 |
| K952075 | PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM | Bayer Corp. | 1995-06-13 |
| K951630 | AURAFLEX PROGESTERONE 150TEST PACK | Organon Teknika Corp. | 1995-05-08 |
| K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1995-04-11 |
| K944211 | IMMULITE PROGESTERONE | Diagnostic Products Corp. | 1994-12-19 |
| K935138 | IMMULITE PROGESTERONE | Diagnostic Products Corp. | 1994-01-11 |
| K933128 | SYNELISA PROGESTERONE | Elias U.S.A., Inc. | 1993-11-05 |
| K933269 | AIA-PACK(R) PROG ASSAY | Tosoh Medics, Inc. | 1993-10-22 |
| K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT | Immunotech Corp. | 1993-10-22 |
Legacy Summary#
summary
FDA Review#
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