ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
FDA 510(k) clearance K863099 · decided 1986-09-16
Clearance details
- K-number
- K863099
- Device name
- ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1986-08-13
- Decision date
- 1986-09-16
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- JJK
- Device class
- 1
- Regulation number
- 862.2720
- 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 |
|---|---|---|
| SPECIAL CONTROL SERUM FOR HDL-CHOLES (K823196) | Boehringer Mannheim Corp. | 1982-11-29 |
| HEPA-SHURE -L (K802120) | Nuclear Medical Laboratories, Inc. | 1980-10-20 |
| WEIL ONCOMETER (IL 186) (K760975) | Instrumentation Laboratory CO | 1977-01-12 |
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 |