VIDAS CHLAMYDIA BLOCKING ASSAY
FDA 510(k) clearance K955627 · decided 1996-10-07
Clearance details
- K-number
- K955627
- Device name
- VIDAS CHLAMYDIA BLOCKING ASSAY
- Applicant
- Biomerieux Vitek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-11
- Decision date
- 1996-10-07
- Days to decision
- 301 days
- Clearance type
- Traditional
- Product code
- LJC
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Rockland, MA, 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 |
|---|---|---|
| CT OIA (K032330) | Thermo Biostar, Inc. | 2004-03-02 |
| IDEIA PCE CHLAMYDIA (K033865) | Dakocytomation, Ltd. | 2004-01-21 |
| CHLAMYDIA IGG ELISA TEST SYSTEM (K033079) | Trinity Biotech USA | 2003-11-26 |
| MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (K982210) | Dade Behring, Inc. | 1998-07-09 |
| CHLAMYDIA IGG ELISA TEST SYSTEM (K962558) | Armkel, LLC | 1997-02-24 |
| ACCESS CHLAMYDIA ASSAY (K960850) | Bio-Rad Laboratories, Inc. | 1997-02-04 |
| IMX SELECT CHLAMYDIA (K936054) | Abbott Laboratories | 1996-05-30 |
| IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (K940564) | Dako Diagnostics , Ltd. | 1996-01-11 |
| CHLAMYDIA OIA (K951010) | Biostar, Inc. | 1995-10-07 |
| QUICKVUE(R) CHLAMYDIA TEST (K946276) | Quidel Corp. | 1995-05-19 |
| ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY (K935807) | Bio-Rad Laboratories, Inc. | 1995-05-19 |
| CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY (K935393) | Bio-Rad Laboratories, Inc. | 1994-09-20 |
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 |