UALB
FDA 510(k) clearance K983774 · decided 1999-01-28
Clearance details
- K-number
- K983774
- Device name
- UALB
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1998-10-26
- Decision date
- 1999-01-28
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- JIR
- Device class
- 1
- Regulation number
- 862.1645
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
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| Minuteful-kidney test (K222921) | Healthy.Io, Ltd. | 2023-09-08 |
| Minuteful - kidney test (K210069) | Healthy.Io, Ltd. | 2022-07-06 |
| Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (K150330) | ACON Laboratories, Inc. | 2015-04-30 |
| TECO MICROALBUMIN 2-1 COMBO STRIPS (K061419) | Teco Diagnostics | 2007-01-26 |
| IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (K022538) | Diagnostic Chemicals, Ltd. (Usa) | 2002-08-23 |
| URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING (K001810) | Flexsite Diagnostics, Inc. | 2000-08-14 |
| IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 (K994035) | Diagnostic Chemicals , Ltd. | 2000-02-01 |
| NEW MULTIPLES REAGENT STRIPS (K992257) | Bayer Corp. | 1999-11-24 |
| MICROALBUSTIX REAGENT STRIPS (OTC) (K991315) | Bayer Corp. | 1999-11-12 |
| HEALTH CHECK URI-TEST PROTEIN IN URINE (K972960) | Tcpi, Inc. | 1998-10-07 |
| MICROALBUSTIX REAGENT STRIPS (K982219) | Bayer Corp. | 1998-08-12 |
| DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA (K972337) | Diagnostic Chemicals , Ltd. | 1997-08-08 |
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 |