PAT PLATELET AGGREGATION TEST— 510(k) K881829
Substantially EquivalentStreck Laboratories, Inc.
FDA 510(k) clearance K881829 for PAT PLATELET AGGREGATION TEST, Substantially Equivalent on 1988-07-01. Applicant: Streck Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Streck Laboratories, Inc.
- Product code
- Code JBX
- Device class
- Class 2
- Regulation
- 21 CFR 864.6675
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Omaha, NE, US
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