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510(k) K902572

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

K902572 is an FDA 510(k) premarket notification submitted by Tech Intl. Co. for the device "SODIUM REAGENT SET". The FDA issued a decision of Substantially Equivalent on July 10, 1990. The device falls under product code CEI (Uranyl Acetate/Zinc Acetate, Sodium), a Class II device regulated under 21 CFR 862.1665. Tech Intl. Co. has at least 10 other 510(k) clearances on record.

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.

  • K915704 — AMYLASE (KINETIC) REAGENT SET (June 28, 1996)
  • K915705 — ACID PHOSPHATASE REAGENT SET (February 27, 1992)
  • K915707 — AMMONIA REAGENT SET (February 26, 1992)
  • 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)

FDA data resources