ABBOTT ARCHITECT TOTAL T3
FDA 510(k) clearance K983434 · decided 1998-11-20
Clearance details
- K-number
- K983434
- Device name
- ABBOTT ARCHITECT TOTAL T3
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-09-29
- Decision date
- 1998-11-20
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- CDP
- Device class
- 2
- Regulation number
- 862.1710
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Abbott Park, IL, 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 |
|---|---|---|
| REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) (K001607) | Repromedix Corp. | 2000-10-05 |
| CHIRON DIAGNOSTICS ACS: 180 FT3 (K991692) | Chiron Diagnostics Corp. | 1999-06-18 |
| 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 |
| 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 |
| NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT (K965058) | Nichols Institute Diagnostics | 1997-03-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |