CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
FDA 510(k) clearance K935393 · decided 1994-09-20
Clearance details
- K-number
- K935393
- Device name
- CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
- Applicant
- Bio-Rad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-08
- Decision date
- 1994-09-20
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- LJC
- Device class
- 1
- Regulation number
- 866.3120
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Chaska, MN, 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 |
| VIDAS CHLAMYDIA BLOCKING ASSAY (K955627) | Biomerieux Vitek, Inc. | 1996-10-07 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MONOLISA ANTI-HBC IGM EIA (P060034/S008) | Bio-Rad Laboratories, Inc. | 2014-03-19 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007) | Bio-Rad Laboratories, Inc. | 2013-12-12 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006) | Bio-Rad Laboratories, Inc. | 2012-11-13 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005) | Bio-Rad Laboratories, Inc. | 2011-04-28 |
| BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003) | Bio-Rad Laboratories, Inc. | 2010-12-30 |
| MONOLISA ANTI-HBC IGM EIA (P060034/S005) | Bio-Rad Laboratories, Inc. | 2010-11-23 |