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510(k) K842103

TOYO JOZO URIC ACID TEST by Advocacy International, Ltd. — Product Code KNK

K842103 is an FDA 510(k) premarket notification submitted by Advocacy International, Ltd. for the device "TOYO JOZO URIC ACID TEST". The FDA issued a decision of Substantially Equivalent on August 12, 1984. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Advocacy International, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1984
Date Received
May 25, 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 Advocacy International, Ltd.

  • K874027 — LIPASE UV [TOYO] (May 27, 1988)
  • K873792 — SEPACELL R-500 AND SEPACELL R-500A (January 19, 1988)
  • K855251 — MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS (February 4, 1986)
  • K855212 — ASAHI AM SERIES DIALYZERS (January 21, 1986)
  • K854259 — SEPACELL R-500 & SEPACELL R-500A (January 8, 1986)
  • K842104 — TOYO JOZO G-GTP TEST (August 10, 1984)
  • K830183 — ASAHI HOLLOW FIBER KIDNEYS NR SERIES (March 17, 1983)
  • K830231 — ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES (March 17, 1983)
  • K823733 — EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR (January 14, 1983)
  • K813037 — FLOWGUARD CATHETERS & CANNALAE (December 14, 1981)

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