AMINOGLYCOSIDE TEST SYSTEM
FDA 510(k) clearance K780048 · decided 1978-01-20
Clearance details
- K-number
- K780048
- Device name
- AMINOGLYCOSIDE TEST SYSTEM
- Applicant
- Nichols Institute Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1978-01-09
- Decision date
- 1978-01-20
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- DID
- Device class
- 2
- Regulation number
- 862.3900
- 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 |
|---|---|---|
| EMIT-ST URINE COCAINE METABOLITE ASSAY (K820773) | Syva Co. | 1982-04-08 |
| PHENYTOIN REAGENT TEST KIT (K802038) | Beckman Instruments, Inc. | 1980-10-23 |
| BIO-MONITOR TOBRAMYCIN (K780950) | Monitor Science Corp. | 1978-08-14 |
| TOBRAMYCIN 125I RIA KIT (K780182) | New England Nuclear | 1978-02-13 |
Recalls involving this device
No recalls on record reference this clearance.