Home / 510(k) Clearances / K862319

510(k) K862319

HBDH (OPTIMIZED) REAGENT by Sigma Chemical Co. — Product Code JMK

K862319 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "HBDH (OPTIMIZED) REAGENT". The FDA issued a decision of Substantially Equivalent on July 7, 1986. The device falls under product code JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase), a Class I device regulated under 21 CFR 862.1380. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1986
Date Received
June 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Device Class
Class I
Regulation Number
862.1380
Review Panel
CH
Submission Type

Other clearances by Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

Other clearances for product code JMK

  • K983860 — MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 (December 27, 1999)
  • K981865 — MTM BIOSCANNER K TEST STRIPS (February 26, 1999)
  • K953452 — KETOREX C SANWA (May 2, 1996)
  • K941427 — SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) (March 13, 1995)
  • K843774 — RAICHEM X-HBDH REAGENT (October 31, 1984)
  • K822739 — AHBD (October 18, 1982)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K781720 — HBDH ENZYME KINETIC REAGENT SET (November 3, 1978)
  • K780104 — ULTRAZYME PLUS HBD (February 13, 1978)
  • K780073 — HBDH REAGENT SET (February 13, 1978)

FDA data resources