PORCINE FACTOR VIII; C REAGENT— 510(k) K952321
Substantially EquivalentHelena Laboratories
FDA 510(k) clearance K952321 for PORCINE FACTOR VIII; C REAGENT, Substantially Equivalent on 1996-03-11. Applicant: Helena Laboratories. Device class: 2.
Clearance details
- Device name as filed
- PORCINE FACTOR VIII;C REAGENT
- Applicant
- Helena Laboratories
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaumont, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.