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510(k) K843938

LINEAR ENZYMATIC URIC ACID SYSTEM by Simmler, Inc. — Product Code KNK

K843938 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "LINEAR ENZYMATIC URIC ACID SYSTEM". The FDA issued a decision of Substantially Equivalent on October 30, 1984. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Simmler, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1984
Date Received
October 9, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Uricase (Colorimetric)
Device Class
Class I
Regulation Number
862.1775
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)

Other clearances for product code KNK

  • K102568 — URIC ACID MODEL 3P39 (May 6, 2011)
  • K062862 — OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (April 6, 2007)
  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)
  • K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (March 18, 2003)
  • K023550 — WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (December 9, 2002)
  • K012038 — JAS URIC ACID LIQUID REAGENT (August 21, 2001)
  • K010421 — WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X5 (April 13, 2001)
  • K993469 — WAKO L-TYPE UA F TEST (November 9, 1999)
  • K991247 — URIC ACID, MODEL UA112-01 (May 25, 1999)

FDA data resources