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510(k) K811810

URIC ACID TEST by Environmental Chemical Specialties — Product Code KNK

K811810 is an FDA 510(k) premarket notification submitted by Environmental Chemical Specialties for the device "URIC ACID TEST". The FDA issued a decision of Substantially Equivalent on July 15, 1981. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Environmental Chemical Specialties has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1981
Date Received
June 25, 1981
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 Environmental Chemical Specialties

  • K812635 — ANEMIA CONTROL (October 2, 1981)
  • K811811 — TDM ANTI-CONVULSANT CONTROL LEVELS I-II (July 10, 1981)
  • K811809 — ANTI-ARRHYTHMIC CONTROL LEVELS I & II (July 10, 1981)
  • K803089 — GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) (January 2, 1981)
  • K792377 — CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL (September 26, 1980)
  • K801854 — SPINAL FLUID CONTROL(HUMAN) (September 16, 1980)
  • K801061 — TOTAL PROTEIN TEST (July 21, 1980)
  • K792374 — QUANTITATIVE CONTROL URINE I (HUMAN) (December 6, 1979)
  • K792375 — ELEVATED LIPID CONTROL (December 6, 1979)
  • K792376 — QUANTITATIVE CONTROL URINE II (HUMAN) (December 6, 1979)

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