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510(k) K872010

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

K872010 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "MULTICHEM LDH-L REAGENT". The FDA issued a decision of Substantially Equivalent on Jun 11, 1987. The device falls under product code CFJ (Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. Simmler, Inc. has 22 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 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
510(k) Exempt

Other clearances by Simmler, Inc.

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

Other clearances for product code CFJ

  • K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT… (Oct 2, 2013)
  • K091544 — S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 (Sep 9, 2009)
  • K051108 — PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM (Jul 8, 2005)
  • K974859 — LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 (Jan 22, 1998)
  • K973589 — LIQUID LDH-L REAGENT SET (Oct 8, 1997)
  • K970684 — LACTATE DEHYDROGENASE (LD) (May 7, 1997)
  • K971398 — LD-L REAGENT (May 2, 1997)
  • K964912 — LACTATE DEHYDROGENASE (Jan 9, 1997)
  • K961431 — LACTATE DEHYDROGENASE REAGENT SET (Jun 3, 1996)
  • K952747 — LACTATE DEHYDROGENASE REAGENT SYSTEM (Aug 7, 1995)

FDA data resources

Source: FDA 510(k) database entry for K872010. Report a data issue: hello@regdatalab.com.