TURBOX ANTITHROMBIN III— 510(k) K884144
Substantially EquivalentUnipath , Ltd.
FDA 510(k) clearance K884144 for TURBOX ANTITHROMBIN III, Substantially Equivalent on 1988-12-20. Applicant: Unipath , Ltd.. Device class: 2.
Clearance details
- Applicant
- Unipath , Ltd.
- Product code
- Code JBQ
- Device class
- Class 2
- Regulation
- 21 CFR 864.7060
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford Mk41 Oqg, GB
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