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510(k) K993469

WAKO L-TYPE UA F TEST by Wako Chemicals USA, Inc. — Product Code KNK

K993469 is an FDA 510(k) premarket notification submitted by Wako Chemicals USA, Inc. for the device "WAKO L-TYPE UA F TEST". The FDA issued a decision of Substantially Equivalent on November 9, 1999. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Wako Chemicals USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1999
Date Received
October 13, 1999
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 Wako Chemicals USA, Inc.

  • K100464 — UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, (February 23, 2011)
  • K080125 — APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 (July 18, 2008)
  • K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (July 17, 2008)
  • K061775 — WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR (February 23, 2007)
  • K062368 — WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP (January 31, 2007)
  • K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (December 30, 2005)
  • K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (December 30, 2005)
  • DEN050002 — LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS (May 19, 2005)
  • K042551 — MULTI-CHEM CALIBRATOR A (November 16, 2004)
  • K042550 — MULTI-LIPID CALIBRATOR (November 8, 2004)

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)
  • K991247 — URIC ACID, MODEL UA112-01 (May 25, 1999)
  • K981604 — CARESIDE URIC ACID (June 25, 1998)

FDA data resources