ALBP
FDA 510(k) clearance K981814 · decided 1998-07-22
Clearance details
- K-number
- K981814
- Device name
- ALBP
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-05-22
- Decision date
- 1998-07-22
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- CJW
- Device class
- 2
- Regulation number
- 862.1035
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
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| ALBUMIN REAGENT (K021636) | Intersect Systems, Inc. | 2002-07-17 |
| RANDOX ALBUMIN (K000483) | Randox Laboratories, Ltd. | 2000-03-31 |
| ALBUMIN BCG, MODEL AL 103-01 (K990978) | A.P. Total Care, Inc. | 1999-05-25 |
| ALBP (K981457) | Abbott Mfg., Inc. | 1998-05-27 |
| ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (K913025) | Em Diagnostic Systems, Inc. | 1991-10-09 |
| ALBUMIN REAGENT SET (K905776) | Biochemical Trade, Inc. | 1991-02-26 |
| ALBUMIN (BCP) (K863226) | Sigma Diagnostics, Inc. | 1986-09-17 |
| EMDS(TM) ALBUMIN TESTPACKS, #67652/95 (K863004) | Em Diagnostic Systems, Inc. | 1986-09-16 |
| VISION ALBUMIN (K862138) | Abbott Laboratories | 1986-06-17 |
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 |