DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT— 510(k) K063675
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K063675 for DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT, Substantially Equivalent on 2007-09-24. Applicant: Diagnostic Hybrids, Inc.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Hybrids, Inc.
- Product code
- Code LJP
- Device class
- Class 1
- Regulation
- 21 CFR 866.3120
- 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.