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510(k) K981865

MTM BIOSCANNER K TEST STRIPS by Polymer Technology Systems, Inc. — Product Code JMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1999
Date Received
May 28, 1998
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

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Other clearances for product code JMK

  • K983860 — MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 (December 27, 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)
  • K781720 — HBDH ENZYME KINETIC REAGENT SET (November 3, 1978)
  • K780104 — ULTRAZYME PLUS HBD (February 13, 1978)
  • K780073 — HBDH REAGENT SET (February 13, 1978)