510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770902Substantially Equivalent

Colorimetric Determ. Socitrate Dehydro.

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

K770902 is the FDA 510(k) clearance record for COLORIMETRIC DETERM. SOCITRATE DEHYDRO., a class I device, cleared for Sigma Chemical Co. on under FDA product code JKH (Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K770902.

Clearance record

Decision date
Received
(59 days to decision)
Product code
JKH Hydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen
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 JKH

Trailing 12 months

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

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