ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K— 510(k) K990957

Name: FDA 510(k) clearance K990957
Creator: U.S. Food and Drug Administration
Published: 1999-05-11

Substantially Equivalent

Astoria-Pacific, Inc.

FDA 510(k) clearance K990957 for ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K, Substantially Equivalent on 1999-05-11. Applicant: Astoria-Pacific, Inc.. Device class: 2.

Clearance details

Applicant: Astoria-Pacific, Inc.
Product code: Code JBL
Device class: Class 2
Regulation: 21 CFR 864.7360
Advisory panel: Hematology
Date received: 1999-03-22
Decision date: 1999-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clackamas, OR, US

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