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510(k) K990957

ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K by Astoria-Pacific, Inc. — Product Code JBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1999
Date Received
March 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Device Class
Class II
Regulation Number
864.7360
Review Panel
HE
Submission Type

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Other clearances for product code JBL

  • K790211 — DEHYDROGENOSE, GLUCOSE PHOSPHATE (March 15, 1979)