DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000— 510(k) K063798
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K063798 for DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000, Substantially Equivalent on 2007-09-21. 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.