510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050790Substantially Equivalent

Spotchem II Ldh Test

Arkray, Inc., Cortlandt Manor NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050790 is the FDA 510(k) clearance record for SPOTCHEM II LDH TEST, a class II device, cleared for Arkray, Inc. on under FDA product code CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase). FDA records list 18 510(k) clearances for Arkray, Inc., from to . As of , FDA records show no recalls naming K050790.

Clearance record

Decision date
Received
(70 days to decision)
Product code
CFH Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Regulation
21 CFR 862.1440
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Arkray, Inc. 510 Furnace Dock Rd., Cortlandt Manor NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CFH

Trailing 12 months

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

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