EMIT-AMD AMIKACIN ASSAY
FDA 510(k) clearance K822657 · decided 1982-09-28
Clearance details
- K-number
- K822657
- Device name
- EMIT-AMD AMIKACIN ASSAY
- Applicant
- Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-03
- Decision date
- 1982-09-28
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- KLQ
- Device class
- 2
- Regulation number
- 862.3035
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Newark, DE, 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 |
| MACRO-VUE CARD TEST, AMIKACIN (K821771) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-25 |
| COAT-A-COUNT AMIKACIN IRA (K820781) | Diagnostic Products Corp. | 1982-04-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBAS INTEGRA 400 PLUS CYCLOSPORINE (P920031/S003) | Dade Behring, Inc. | 2002-07-24 |
| COBAS INTEGRA CYCLOSPORINE (P920031/S002) | Dade Behring, Inc. | 2002-02-26 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031/S001) | Dade Behring, Inc. | 2000-08-11 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (P920031) | Dade Behring, Inc. | 1996-10-02 |