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510(k) K880277

URIC ACID REAGENT SET by Tech-Neal Scientific, Inc. — Product Code KNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1988
Date Received
January 21, 1988
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

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  • K881241 — TOTAL BILIRUBIN REAGENT (May 27, 1988)
  • K880237 — CHOLESTEROL (April 28, 1988)
  • K881240 — CHLORIDE REAGENT SET (April 28, 1988)
  • K881237 — CREATINE KINASE (CK) REAGENT SET (April 28, 1988)
  • K880843 — CREATININE REAGENT SET (KINETIC) (April 5, 1988)
  • K880844 — ALBUMIN REAGENT SET (April 5, 1988)
  • K880845 — CALCIUM REAGENT SET (April 5, 1988)

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