ACCESS TOTAL T3 ASSAY (MODIFICATION)
FDA 510(k) clearance K955435 · decided 1996-01-24
Clearance details
- K-number
- K955435
- Device name
- ACCESS TOTAL T3 ASSAY (MODIFICATION)
- Applicant
- Bio-Rad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-10-02
- Decision date
- 1996-01-24
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- CDP
- Device class
- 2
- Regulation number
- 862.1710
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 (K991311) | Biocheck, Inc. | 1999-06-02 |
| AIA-PACK FT3 ASSAY (K991252) | Tosoh Medics, Inc. | 1999-05-11 |
| OPTICOAT T3 EIA KIT (K981824) | Biotecx Laboratories, Inc. | 1998-12-22 |
| ABBOTT ARCHITECT FREE T3 (K983439) | Abbott Laboratories | 1998-11-20 |
| ABBOTT ARCHITECT TOTAL T3 (K983434) | Abbott Laboratories | 1998-11-20 |
| AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK (K974027) | Alfa Biotech (Uk) , Ltd. | 1998-02-02 |
| IMMULITE FREE T3 (K974634) | Diagnostic Products Corp. | 1998-01-02 |
| ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973966) | Beckman Instruments, Inc. | 1997-10-31 |
| TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (K971779) | Monobind | 1997-06-16 |
| DSL ACTIVE T3 EIA (K971270) | Diagnostic Systems Laboratories, Inc. | 1997-05-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative recall (Z-2227-2012) | Beckman Coulter Inc. | 2012-08-20 |
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 |