COAGULATION ARP— 510(k) K790826
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K790826 for COAGULATION ARP, Substantially Equivalent on 1979-05-31. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Applicant
- Helena Laboratories
- Product code
- Code JPK
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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