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510(k) K902572

SODIUM REAGENT SET by Tech Intl. Co. — Product Code CEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1990
Date Received
June 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uranyl Acetate/Zinc Acetate, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by Tech Intl. Co.

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  • K914158 — URIC ACID REAGENT SET (February 21, 1992)
  • K915706 — LIPASE REAGENT SET (February 18, 1992)
  • K914160 — CHOLESTEROL REGEANT SET (January 30, 1992)
  • K915710 — AMYLASE (COLORIMETRIC) REAGENT SET (January 30, 1992)
  • K915709 — CREATINE KINASE-MB (CK-MB) REAGENT SET (January 27, 1992)
  • K914159 — GLUCOSE REAGENT SET (January 27, 1992)
  • K915708 — INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET (January 22, 1992)

Other clearances for product code CEI

  • K043268 — SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 (February 15, 2005)
  • K914039 — SODIUM REAGENT SET (October 31, 1991)
  • K832552 — SODIUM TEST KIT (September 20, 1983)