HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT— 510(k) K911345
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K911345 for HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT, Substantially Equivalent on 1991-06-17. Applicant: Diagnostic Hybrids, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Hybrids, 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
- Athens, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.