LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
FDA 510(k) clearance K040923 · decided 2004-07-22
Clearance details
- K-number
- K040923
- Device name
- LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
- Applicant
- Ibl GmbH
- Decision
- Substantially Equivalent
- Date received
- 2004-04-08
- Decision date
- 2004-07-22
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- JLS
- Device class
- 1
- Regulation number
- 862.1620
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Stroudsburg, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROGESTERONE ELISA (K973898) | Kmi Diagnostics, Inc. | 1997-11-13 |
| VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) (K972133) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-06-24 |
| OPUS PROGESTERONE (K971725) | Behring Diagnostics, Inc. | 1997-06-18 |
| ELECSYS PROGESTERONE ASSAY (K964841) | Boehringer Mannheim Corp. | 1997-03-24 |
| VIDAS PROESTERONE (PRG) (30 409) (K965084) | bioMerieux, Inc. | 1997-01-09 |
| AXSYM PROGESTERONE (K955025) | Abbott Laboratories | 1996-03-07 |
| ACCESS PROGESTERONE ASSAY (K955769) | Bio-Rad Laboratories, Inc. | 1996-02-05 |
| PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (K952075) | Bayer Corp. | 1995-06-13 |
| AURAFLEX PROGESTERONE 150TEST PACK (K951630) | Organon Teknika Corp. | 1995-05-08 |
| STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (K950570) | Baxter Diagnostics, Inc. | 1995-04-11 |
| IMMULITE PROGESTERONE (K944211) | Diagnostic Products Corp. | 1994-12-19 |
| IMMULITE PROGESTERONE (K935138) | Diagnostic Products Corp. | 1994-01-11 |
Recalls involving this device
No recalls on record reference this clearance.