510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770519Substantially Equivalent

Reagent System 153-UV

Sigma Chemical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770519 is the FDA 510(k) clearance record for REAGENT SYSTEM 153-UV, a class I device, cleared for Sigma Chemical Co. on under FDA product code JKG (L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K770519.

Clearance record

Decision date
Received
(77 days to decision)
Product code
JKG L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase
Regulation
21 CFR 862.1420
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sigma Chemical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JKG

Trailing 12 months

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

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