CRYOCHECK CLOT APCR— 510(k) K060284

Substantially Equivalent

Precision Biologic, Inc.

FDA 510(k) clearance K060284 for CRYOCHECK CLOT APCR, Substantially Equivalent on 2006-05-10. Applicant: Precision Biologic, Inc.. Device class: 2.

Clearance details

Applicant: Precision Biologic, Inc.
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2006-02-03
Decision date: 2006-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, N.S., 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.