510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862319Substantially Equivalent

Hbdh (Optimized) Reagent

Sigma Chemical Co., St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862319 is the FDA 510(k) clearance record for HBDH (OPTIMIZED) REAGENT, a class I device, cleared for Sigma Chemical Co. on under FDA product code JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase). FDA records list 231 510(k) clearances for Sigma Chemical Co., from to . As of , FDA records show no recalls naming K862319.

Clearance record

Decision date
Received
(19 days to decision)
Product code
JMK Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Regulation
21 CFR 862.1380
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sigma Chemical Co. P.O. Box 14508, St. Louis MO
Third party review
No

Clearances, product code JMK

Trailing 12 months

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

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