D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT— 510(k) K092882
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K092882 for D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT, Substantially Equivalent on 2009-10-21. Applicant: Diagnostic Hybrids, Inc.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Hybrids, Inc.
- Product code
- Code GNW
- Device class
- Class 1
- Regulation
- 21 CFR 866.3330
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, OH, US
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