AMES TDA KANAMYCIN TEST-CONTROL SERUM
FDA 510(k) clearance K832769 · decided 1983-09-29
Clearance details
- K-number
- K832769
- Device name
- AMES TDA KANAMYCIN TEST-CONTROL SERUM
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-16
- Decision date
- 1983-09-29
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- KJI
- Device class
- 2
- Regulation number
- 862.3520
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, 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 |
|---|---|---|
| ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY (K823370) | Syva Co. | 1982-12-03 |
| KENAMYCIN FLUORESCENT IMMUNOASSAY FIA (K823062) | American Diagnostic Corp. | 1982-11-10 |
| TDX KENAMYCIN (K822808) | Abbott Laboratories | 1982-10-08 |
| RIA KIT, KANAMYCIN (K782125) | Diagnostic Products Corp. | 1979-01-10 |
| KANAMYCIN RIA (K772038) | Monitor Science Corp. | 1978-01-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |