N-ASSAY TIA APO A1/B MULTI CALIBRATOR— 510(k) K964294
Substantially EquivalentCrestat Diagnostics, Inc.
FDA 510(k) clearance K964294 for N-ASSAY TIA APO A1/B MULTI CALIBRATOR, Substantially Equivalent on 1997-08-01. Applicant: Crestat Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Crestat Diagnostics, Inc.
- Product code
- Code DER
- Device class
- Class 2
- Regulation
- 21 CFR 866.5580
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrieta, CA, US
Recent devices under product code DER
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