TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT
FDA 510(k) clearance K854944 · decided 1986-08-27
Clearance details
- K-number
- K854944
- Device name
- TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-12-10
- Decision date
- 1986-08-27
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- DAH
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Irving, TX, 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 |
|---|---|---|
| TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 (K931247) | Helena Laboratories | 1993-04-27 |
| TITAN GEL (K905149) | Helena Laboratories | 1991-01-03 |
| REP(R) IMMUNOFIX (K901805) | Helena Laboratories | 1990-06-06 |
| IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (K884074) | Orion Diagnostica, Inc. | 1988-10-27 |
| TECHNICON DPA-1 IMMUNOGLOBULIN G (K883494) | Technicon Instruments Corp. | 1988-09-07 |
| DAKO ITA, IMMUNOGLOBULIN M (IGM) (K862184) | Dako Corp. | 1986-08-19 |
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 |