VISION TOTAL PROTEIN
FDA 510(k) clearance K861798 · decided 1986-06-17
Clearance details
- K-number
- K861798
- Device name
- VISION TOTAL PROTEIN
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1986-05-09
- Decision date
- 1986-06-17
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- CEK
- Device class
- 2
- Regulation number
- 862.1635
- 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 |
|---|---|---|
| HICHEM TOTAL PROTEIN REAGENT (K992846) | Elan Holdings, Inc. | 1999-10-18 |
| TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 (K973108) | Diagnostic Chemicals , Ltd. | 1998-03-02 |
| CARESIDE TOTAL PROTEIN (K980042) | Exigent Diagnostics, Inc. | 1998-02-04 |
| TOTAL PROTEIN OR TP (K971524) | Carolina Liquid Chemistries Corp. | 1997-05-16 |
| CSF/URINE TOTAL PROTEIN (K961864) | Teco Diagnostics | 1996-10-24 |
| STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (K955905) | Solarcare Technologies Corp,Inc. | 1996-05-30 |
| TOTAL PROTEIN REAGENT (K955936) | Derma Media Lab., Inc. | 1996-03-12 |
| DUPONT DIMENSION TOTAL PROTEIN METHOD (K950920) | Dupont Medical Products | 1995-08-11 |
| TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (K950234) | Emd Chemicals, Inc. | 1995-06-14 |
| TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (K950128) | Emd Chemicals, Inc. | 1995-05-15 |
| TOTAL PROTEIN QVET (K943004) | Prisma Systems | 1994-12-09 |
| SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY (K941496) | Solarcare, Inc. | 1994-10-27 |
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 |