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510(k) K834045

URIC ACID REAGENT SET by Sterling Biochemical, Inc. — Product Code KNK

K834045 is an FDA 510(k) premarket notification submitted by Sterling Biochemical, Inc. for the device "URIC ACID REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Sterling Biochemical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
November 23, 1983
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 Sterling Biochemical, Inc.

  • K844998 — GLUCOSE(HEXOKINASE) REAGENT SET (January 18, 1985)
  • K844251 — ALT/GPT REAGENT SET (January 8, 1985)
  • K843332 — ALKALINE PHOSPHATASE REAGENT SET (September 14, 1984)
  • K842521 — AST/GOT REAGENT SET UV RATE (August 12, 1984)
  • K840064 — UREA NITROGEN REAGENT SET (June 14, 1984)
  • K834084 — HYDROXYBUTYRATE DEHYDROGENASE REAGENT (February 4, 1984)
  • K833864 — AMYLASE REAGENT SET-MODIFIED CARAWAY (January 13, 1984)
  • K833062 — SERUM CHOLINESTERASE REAGENT SET (November 25, 1983)
  • K831874 — LIPASE REAGENT SET (August 12, 1983)
  • K831415 — LACTIC DEHYDROGENASE REAGENT SET (June 16, 1983)

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