CYBREX AMIKACIN
FDA 510(k) clearance K802669 · decided 1980-11-12
Clearance details
- K-number
- K802669
- Device name
- CYBREX AMIKACIN
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1980-10-27
- Decision date
- 1980-11-12
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- KLQ
- Device class
- 2
- Regulation number
- 862.3035
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| QMS AMIKACIN REAGENTS (K052815) | Seradyn, Inc. | 2005-11-01 |
| RANDOX AMIKACIN (K033884) | Randox Laboratories, Ltd. | 2004-06-09 |
| INNOFLUOR AMIKACIN ASSAY SYSTEM (K955570) | Oxis Intl., Inc. | 1996-02-09 |
| INNOFLUOR (TM) AMIKACIN REAGENT SET (K903100) | Innotron of Oregon, Inc. | 1990-08-09 |
| FPR AMIKACIN KIT (K894517) | Colony Laboratories, Inc. | 1989-09-28 |
| COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR (K852317) | Roche Diagnostic Systems, Inc. | 1985-06-25 |
| AMIKACIN ANALYTICAL TEST PACK ACA (K843211) | E.I. Dupont DE Nemours & Co., Inc. | 1984-09-12 |
| IMMPULSE AMIKACIN ASSAY REAGENTS (K841161) | Paragon Diagnostics, Inc. | 1984-05-02 |
| EMIT QST AMIKACIN ASSAY (K840193) | Syva Co. | 1984-03-23 |
| STRATUS AMIKACIN FLUOROMETRIC (K832336) | American Dade | 1983-08-31 |
| EMIT-AMD AMIKACIN ASSAY (K822657) | Dade Behring, Inc. | 1982-09-28 |
| MACRO-VUE CARD TEST, AMIKACIN (K821771) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-25 |
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 |