FRESH FROZEN CELLS— 510(k) K940502
Substantially EquivalentDiagnostic Hybrids, Inc.
FDA 510(k) clearance K940502 for FRESH FROZEN CELLS, Substantially Equivalent on 1994-06-16. Applicant: Diagnostic Hybrids, Inc.. Device class: 1.
Clearance details
- Applicant
- Diagnostic Hybrids, Inc.
- Product code
- Code KIR
- Device class
- Class 1
- Regulation
- 21 CFR 864.2280
- Advisory panel
- Hematology
- 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.