PLATELET AGGREGATION REAGENTS— 510(k) K800146
Substantially EquivalentPacific Hemostasis
FDA 510(k) clearance K800146 for PLATELET AGGREGATION REAGENTS, Substantially Equivalent on 1980-02-05. Applicant: Pacific Hemostasis. Device class: 2.
Clearance details
- Applicant
- Pacific Hemostasis
- 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
- Mchenry, IL, US
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More clearances from Pacific Hemostasis
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