ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)— 510(k) K012701
Substantially EquivalentAccumetrics, Inc.
FDA 510(k) clearance K012701 for ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA), Substantially Equivalent on 2002-06-12. Applicant: Accumetrics, Inc.. Device class: 2.
Clearance details
- Applicant
- Accumetrics, Inc.
- Product code
- Code JOZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5700
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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