510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010844Substantially Equivalent

Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part No. 80-8000-13K

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

K010844 is the FDA 510(k) clearance record for ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K, a class II device, cleared for Astoria-Pacific, Inc. on under FDA product code NAK (System, Test, Biotinidase). FDA records list 9 510(k) clearances for Astoria-Pacific, Inc., from to . As of , FDA records show no recalls naming K010844.

Clearance record

Decision date
Received
(184 days to decision)
Product code
NAK System, Test, Biotinidase
Regulation
21 CFR 862.1118
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Astoria-Pacific, Inc. 15130 SE 82nd Dr., Clakamas OR
510(k) summary
Summary
Third party review
No

Clearances, product code NAK

Trailing 12 months

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

FDA records show no clearances under product code NAK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NAK, 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