PREALBUMIN ENZYME IMMUNOASSAY
FDA 510(k) clearance K821135 · decided 1983-05-05
Clearance details
- K-number
- K821135
- Device name
- PREALBUMIN ENZYME IMMUNOASSAY
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1982-04-20
- Decision date
- 1983-05-05
- Days to decision
- 380 days
- Clearance type
- Traditional
- Product code
- JZJ
- Device class
- 1
- Regulation number
- 866.5060
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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 |
|---|---|---|
| RANDOX PREALBUMIN (K000661) | Randox Laboratories, Ltd. | 2000-04-13 |
| TINA-QUANT PREALBUMIN (K972638) | Boehringer Mannheim Corp. | 1998-01-09 |
| HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT (K951966) | Kent Laboratories, Inc. | 1995-06-01 |
| PREALBUMIN IMMUNOLOGICAL NL TEST KIT (K913672) | The Binding Site, Ltd. | 1991-12-20 |
| SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (K884298) | Atlantic Antibodies | 1988-11-02 |
| SPQ(TM) TEST SYSTEM FOR PREALBUMIN (K884297) | Atlantic Antibodies | 1988-11-02 |
| QM300 PREALBUMIN ANTIBODY PACK (K883002) | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-09-22 |
| ANTISERUM TO HUMAN PREALBUMIN (K850686) | Kent Laboratories, Inc. | 1985-11-01 |
| LASER PREALBUMIN TEST (K851912) | Behring Diagnostics, Inc. | 1985-06-21 |
| LAS-R HUMAN PREALBUMIN TEST (K772329) | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-03 |
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 |