BIO-MONITOR AMIKACIN
FDA 510(k) clearance K780949 · decided 1978-08-14
Clearance details
- K-number
- K780949
- Device name
- BIO-MONITOR AMIKACIN
- Applicant
- Monitor Science Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-09
- Decision date
- 1978-08-14
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- KLP
- Device class
- 2
- Regulation number
- 862.3035
- 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 |
|---|---|---|
| ONLINE TDM AMIKA (K032279) | Roche Diagnostics Corp. | 2003-10-10 |
| EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 (K873426) | Em Diagnostic Systems, Inc. | 1987-10-29 |
| BACTEC (K790899) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-05-23 |
Recalls involving this device
No recalls on record reference this clearance.