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510(k) K781720

HBDH ENZYME KINETIC REAGENT SET by Medical Analysis Systems, Inc. — Product Code JMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1978
Date Received
October 11, 1978
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 Medical Analysis Systems, Inc.

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  • K041194 — ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, (August 16, 2004)
  • K040880 — MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (April 28, 2004)
  • K032826 — MAS PAR TDM (October 9, 2003)
  • K032335 — MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL (August 19, 2003)
  • K031890 — MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL (July 16, 2003)
  • K031392 — MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (July 1, 2003)
  • K031441 — URICHEMTRAK LIQUID ASSAYED URINE CONTROL (July 1, 2003)
  • K031364 — MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 (May 30, 2003)
  • K030942 — MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL (April 28, 2003)

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)
  • 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)
  • K780104 — ULTRAZYME PLUS HBD (February 13, 1978)
  • K780073 — HBDH REAGENT SET (February 13, 1978)