VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
FDA 510(k) clearance K923903 · decided 1993-08-09
Clearance details
- K-number
- K923903
- Device name
- VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-04
- Decision date
- 1993-08-09
- Days to decision
- 370 days
- Clearance type
- Traditional
- Product code
- LJY
- Device class
- 1
- Regulation number
- 866.3380
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hazelwood, MO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biomerieux Vitek
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MUMPS IGG ELISA TEST SYSTEM (K991274) | Columbia Bioscience, Inc. | 1999-09-03 |
| SERAQUEST MUMPS IGG (K980059) | Quest Intl., Inc. | 1998-04-23 |
| MUMPS IGG ELISA TESTY (K971857) | Gull Laboratories, Inc. | 1997-11-04 |
| MUMPS IGG TEST (K961204) | Zeus Scientific, Inc. | 1996-07-18 |
| MUMPS STAT (K925209) | Biowhittaker Molecular Applications, Inc. | 1994-10-14 |
| PHARMACIA MUMPS IGG ELISA (K897006) | Pharmacia Eni Diagnostics, Inc. | 1990-07-26 |
| MUMPSELISA TEST KIT (K830045) | M.A. Bioproducts | 1983-05-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL (N50510/S146) | Biomerieux Vitek, Inc. | 2001-10-17 |
| VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE (N50510/S145) | Biomerieux Vitek, Inc. | 2001-06-25 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN (N50510/S143) | Biomerieux Vitek, Inc. | 2001-06-13 |
| VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN (N50510/S144) | Biomerieux Vitek, Inc. | 2001-06-13 |
| VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN (N50510/S142) | Biomerieux Vitek, Inc. | 2001-05-30 |
| VITEK 2 GRAM POSITIVE AST FOR SPARFLOXACIN (N50510/S141) | Biomerieux Vitek, Inc. | 2001-05-14 |
| VITEK(R) 2 GRAM POSITIVE AST FOR MINOCYCLINE (N50510/S140) | Biomerieux Vitek, Inc. | 2001-03-09 |
| VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN (N50510/S138) | Biomerieux Vitek, Inc. | 2000-08-11 |