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510(k) K872010

MULTICHEM LDH-L REAGENT by Simmler, Inc. — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1987
Date Received
May 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type

Other clearances by Simmler, Inc.

  • K895745 — SICKLE CELL SOLUBILITY TEST KIT (November 29, 1989)
  • K874903 — MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (February 11, 1988)
  • K874595 — MULTICHEM (R) MAGNESIUM REAGENT (January 21, 1988)
  • K874820 — MULTICHEM HDL PRECIPITATING REAGENT #S0914 (January 7, 1988)
  • K874812 — MULTICHEM CHLORIDE REAGENT S0933 (December 18, 1987)
  • K874311 — MULTICHEM (R) TOTAL BILIRUBIN (November 25, 1987)
  • K874049 — MULTICHEM ALBUMIN REAGENT S0902 (October 29, 1987)
  • K874038 — MULTICHEM INORGANIC PHOSPHOROUS S0923 (October 28, 1987)
  • K873725 — MULTICHEM CREATININE REAGENT S0917 (October 20, 1987)
  • K873761 — MULTICHEM ALKALINE PHOSPHATASE (S0903) (October 7, 1987)

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  • K961431 — LACTATE DEHYDROGENASE REAGENT SET (June 3, 1996)
  • K952747 — LACTATE DEHYDROGENASE REAGENT SYSTEM (August 7, 1995)