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510(k) K953452

KETOREX C SANWA by Ihara Medics U.S., Inc. — Product Code JMK

K953452 is an FDA 510(k) premarket notification submitted by Ihara Medics U.S., Inc. for the device "KETOREX C SANWA". The FDA issued a decision of Substantially Equivalent on May 2, 1996. 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. Ihara Medics U.S., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1996
Date Received
July 18, 1995
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 Ihara Medics U.S., Inc.

  • K912373 — KETO-340 II (July 1, 1991)
  • K903365 — KETOREX SANWA STANDARDS (December 20, 1990)
  • K903367 — KETONE TEST A SANWA STANDARD (November 20, 1990)
  • K903366 — KETONE TEST B SANWA STANDARD (November 20, 1990)

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)
  • K941427 — SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) (March 13, 1995)
  • K862319 — HBDH (OPTIMIZED) REAGENT (July 7, 1986)
  • 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)
  • K780073 — HBDH REAGENT SET (February 13, 1978)
  • K780104 — ULTRAZYME PLUS HBD (February 13, 1978)

FDA data resources