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510(k) K811810

URIC ACID TEST by Environmental Chemical Specialties — Product Code KNK

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

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  • K803089 — GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) (January 2, 1981)
  • K792377 — CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL (September 26, 1980)
  • K801854 — SPINAL FLUID CONTROL(HUMAN) (September 16, 1980)
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  • K792376 — QUANTITATIVE CONTROL URINE II (HUMAN) (December 6, 1979)
  • K792375 — ELEVATED LIPID CONTROL (December 6, 1979)
  • K792374 — QUANTITATIVE CONTROL URINE I (HUMAN) (December 6, 1979)

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  • K993469 — WAKO L-TYPE UA F TEST (November 9, 1999)
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