510(k) K780951
- Device
- BIO-MONITOR GENTAMICIN
- Applicant
- MONITOR SCIENCE CORP.
- 510(k) number
- K780951
- Product code
- DKD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-14
- Date received
- 1978-06-09
- Regulation
- 862.3450
- Classification name
- Bacillus Subtilis, Microbiological Assay, Gentamicin
- 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 DKD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760942 | GENTASAK | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-07 |
Legacy Summary#
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FDA Review#
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