ABBOTT CATION SUPPLEMENT SOLUTION
FDA 510(k) clearance K853546 · decided 1985-09-06
Clearance details
- K-number
- K853546
- Device name
- ABBOTT CATION SUPPLEMENT SOLUTION
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-08-26
- Decision date
- 1985-09-06
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- JSK
- Device class
- 1
- Regulation number
- 866.2450
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Irving, TX, 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 |
|---|---|---|
| ATS NAC-PAC SET (K881949) | Alpha-Tec Systems, Inc. | 1988-05-25 |
| ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (K881879) | Alpha-Tec Systems, Inc. | 1988-05-13 |
| HEMOGLOBIN POWDER (K881566) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (K861997) | Hazleton Research Products, Inc. | 1986-06-10 |
| GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (K861824) | Flow Laboratories, Inc. | 1986-05-20 |
| GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (K861823) | Flow Laboratories, Inc. | 1986-05-20 |
| PENICILLIN-STREPTOMYCIN-FUNGIZONE (K861791) | Flow Laboratories, Inc. | 1986-05-20 |
| KWI (TM) G-CO/TWO (K855172) | Micro-Bio-Logics | 1986-02-20 |
| SUPLEX & SUPLEX DILUENT (K850302) | Pro-Lab, Inc. | 1985-03-22 |
| C.N.V.T. (K850299) | Pro-Lab, Inc. | 1985-03-20 |
| CAMPYLOBACTER SUPPLEMENT-BLASER/WANG (K850307) | Pro-Lab, Inc. | 1985-03-20 |
| MUCOLYSE (K850300) | Pro-Lab, Inc. | 1985-03-20 |
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 |