D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT— 510(k) K081164
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K081164 for D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT, Substantially Equivalent on 2008-06-13. Applicant: Diagnostic Hybrids, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Hybrids, Inc.
- Product code
- Code LIN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3175
- 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.