510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894011Substantially Equivalent

Total Galactose

Alpkem Corp., Clackamas OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894011 is the FDA 510(k) clearance record for TOTAL GALACTOSE, a class II device, cleared for Alpkem Corp. on under FDA product code KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase). FDA records list 33 510(k) clearances for Alpkem Corp., from to . As of , FDA records show no recalls naming K894011.

Clearance record

Decision date
Received
(219 days to decision)
Product code
KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Regulation
21 CFR 862.1315
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Alpkem Corp. Box 1260, Clackamas OR
Third party review
No

Clearances, product code KQP

Trailing 12 months

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

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