TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
FDA 510(k) clearance K792188 · decided 1979-11-27
Clearance details
- K-number
- K792188
- Device name
- TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1979-10-31
- Decision date
- 1979-11-27
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- CDX
- Device class
- 2
- Regulation number
- 862.1700
- 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 |
|---|---|---|
| ELECSYS T4 ASSAY (K961490) | Boehringer Mannheim Corp. | 1996-06-13 |
| ACTIVE THYROXINE RIA (K954312) | Diagnostic Systems Laboratories, Inc. | 1995-10-07 |
| DELFIA NEONATAL THYROXINE KIT (K943416) | Wallac OY | 1995-03-10 |
| AXSYM(TM) TOTAL T4 (K934384) | Abbott Laboratories | 1994-06-21 |
| TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 (K932980) | Sigma Diagnostics, Inc. | 1993-10-18 |
| STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO (K933426) | Baxter Diagnostics, Inc. | 1993-08-26 |
| IQ TT4 ASSAY (K931295) | Becton Dickinson Advanced Diagnostics | 1993-07-20 |
| AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (K926563) | Bio-Chem Laboratory Systems, Inc. | 1993-03-18 |
| ABBOTT IMX T4 (K925110) | Abbott Laboratories | 1993-01-26 |
| ABBOTT TDX/TDXFLX TT4 (K925109) | Abbott Laboratories | 1993-01-04 |
| TECHNICON DAX SYSTEM THYROXINE (T4) METHOD (K922945) | Heraeus Kulzer, Inc. | 1992-10-14 |
| THYROXINE (T4) COATED TUBE RIA (K921935) | Monobind | 1992-07-07 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |