510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990957Substantially Equivalent

Astoria-Pacific Spotcheck G6pd Kit 50 Hr, Model 80-3000-13K

Astoria-Pacific, Inc., Clackamas OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990957 is the FDA 510(k) clearance record for ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K, a class II device, cleared for Astoria-Pacific, Inc. on under FDA product code JBL (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative). FDA records list 9 510(k) clearances for Astoria-Pacific, Inc., from to . As of , FDA records show no recalls naming K990957.

Clearance record

Decision date
Received
(50 days to decision)
Product code
JBL Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Regulation
21 CFR 864.7360
Device class
Class II
Review panel
Hematology
Applicant
Astoria-Pacific, Inc. 14600 SE 82nd Dr., Clackamas OR
510(k) summary
Summary
Third party review
No

Clearances, product code JBL

Trailing 12 months

FDA records hold no clearances under product code JBL in the trailing twelve months.

FDA records show no clearances under product code JBL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JBL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260