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510(k) K895821

URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS by Catachem, Inc. — Product Code KNK

K895821 is an FDA 510(k) premarket notification submitted by Catachem, Inc. for the device "URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS". The FDA issued a decision of Substantially Equivalent on December 5, 1989. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Catachem, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1989
Date Received
September 29, 1989
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 Catachem, Inc.

  • K062503 — CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT (January 19, 2007)
  • K945408 — 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (February 22, 1995)
  • K932871 — UIBC FOR DISCREET RANDOM ACCESS ANALYZER (September 8, 1993)
  • K903341 — MAGNESIUM (August 22, 1990)
  • K902326 — AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS (July 31, 1990)
  • K902877 — TOTAL IRON FOR MANUAL/AUTOMATED (July 27, 1990)
  • K895748 — BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS (December 21, 1989)
  • K894715 — CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS (November 8, 1989)
  • K894476 — CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION (October 12, 1989)
  • K894389 — CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS (October 12, 1989)

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