CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)— 510(k) K990296

Name: FDA 510(k) clearance K990296
Creator: U.S. Food and Drug Administration
Published: 1999-03-18

Substantially Equivalent

Precision Biologic

FDA 510(k) clearance K990296 for CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML), Substantially Equivalent on 1999-03-18. Applicant: Precision Biologic. Device class: 2.

Clearance details

Applicant: Precision Biologic
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1999-01-28
Decision date: 1999-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, N.S., CA

Download summary PDF View on FDA.gov ↗

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