Cryocheck Hex LA— 510(k) K193556

Substantially Equivalent

Precision Biologic

FDA 510(k) clearance K193556 for Cryocheck Hex LA, Substantially Equivalent on 2020-10-23. Applicant: Precision Biologic. Device class: 2.

Clearance details

Applicant: Precision Biologic
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2019-12-23
Decision date: 2020-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Darmouth, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.