CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)— 510(k) K990579

Name: FDA 510(k) clearance K990579
Creator: U.S. Food and Drug Administration
Published: 1999-07-23

Substantially Equivalent

Precision Biologic

FDA 510(k) clearance K990579 for CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML), Substantially Equivalent on 1999-07-23. Applicant: Precision Biologic. Device class: 1.

Clearance details

Applicant: Precision Biologic
Product code: Code GIR
Device class: Class 1
Regulation: 21 CFR 864.8950
Advisory panel: Hematology
Date received: 1999-02-23
Decision date: 1999-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, N.S., CA

Download summary PDF View on FDA.gov ↗

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