510(k) K780950
- Device
- BIO-MONITOR TOBRAMYCIN
- Applicant
- MONITOR SCIENCE CORP.
- 510(k) number
- K780950
- Product code
- DID
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-14
- Date received
- 1978-06-09
- Regulation
- 862.3900
- Classification name
- Bacillus Subtilis Microbiology Assay, Tobramycin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DID #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K820773 | EMIT-ST URINE COCAINE METABOLITE ASSAY | Syva Co. | 1982-04-08 |
| K802038 | PHENYTOIN REAGENT TEST KIT | Beckman Instruments, Inc. | 1980-10-23 |
| K780182 | TOBRAMYCIN 125I RIA KIT | New England Nuclear | 1978-02-13 |
| K780048 | AMINOGLYCOSIDE TEST SYSTEM | Nichols Institute Diagnostics | 1978-01-20 |
Legacy Summary#
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FDA Review#
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