510(k) K924113
- Device
- Abuscreen Online For Cocaine Metabolite
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K924113
- Product code
- DLN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-12-28
- Date received
- 1992-08-13
- Regulation
- 862.3250
- Classification name
- Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL L KRIEGER
- Address
- 1080 Us Hwy. 202 Branchburg NJ US 08876 08876
Source Documents#
510(k) summary PDF not indicated by FDA