510(k) K760942
- Device
- GENTASAK
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- 510(k) number
- K760942
- Product code
- DKD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-03-07
- Date received
- 1976-11-01
- Regulation
- 862.3450
- Classification name
- Bacillus Subtilis, Microbiological Assay, Gentamicin
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DKD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K780951 | BIO-MONITOR GENTAMICIN | Monitor Science Corp. | 1978-08-14 |