COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.— 510(k) K870733
Substantially EquivalentEnzo Biochem, Inc.
FDA 510(k) clearance K870733 for COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA., Substantially Equivalent on 1987-05-26. Applicant: Enzo Biochem, Inc.. Device class: 2.
Clearance details
- Applicant
- Enzo Biochem, Inc.
- Product code
- Code GQN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3305
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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