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510(k) K915704

AMYLASE (KINETIC) REAGENT SET by Tech Intl. Co. — Product Code CJD

K915704 is an FDA 510(k) premarket notification submitted by Tech Intl. Co. for the device "AMYLASE (KINETIC) REAGENT SET". The FDA issued a decision of Substantially Equivalent on June 28, 1996. The device falls under product code CJD (Nitrosalicylate Reduction, Amylase), a Class II device regulated under 21 CFR 862.1070. Tech Intl. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1996
Date Received
November 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitrosalicylate Reduction, Amylase
Device Class
Class II
Regulation Number
862.1070
Review Panel
CH
Submission Type

Other clearances by Tech Intl. Co.

  • 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)
  • K915710 — AMYLASE (COLORIMETRIC) REAGENT SET (January 30, 1992)
  • K914160 — CHOLESTEROL REGEANT 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)
  • K914171 — IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE (December 18, 1991)

FDA data resources