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510(k) K915706

LIPASE REAGENT SET by Tech Intl. Co. — Product Code CET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1992
Date Received
November 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Olive Oil Emulsion (Turbidimetric), Lipase
Device Class
Class I
Regulation Number
862.1465
Review Panel
CH
Submission Type

Other clearances by Tech Intl. Co.

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  • K915707 — AMMONIA REAGENT SET (February 26, 1992)
  • K914158 — URIC ACID REAGENT SET (February 21, 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)

Other clearances for product code CET

  • K970124 — LIPASE REAGENT SET (COLIPASE METHOD) (March 6, 1997)
  • K940457 — LIPASE REAGENT SYSTEM (June 2, 1994)
  • K901858 — MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST (June 12, 1990)
  • K893718 — DELTATEST (R) LIPASE II (September 28, 1989)
  • K885078 — LIPASE SR LIQUID STABLE REAGENT SET (March 13, 1989)
  • K864438 — BECKMAN EPSILON(TM) LIPASE TEST KIT (March 12, 1987)
  • K862440 — PARAMAX LIPASE REAGENT (August 4, 1986)
  • K844240 — ENZYGNOST LIPASE TEST (February 12, 1985)
  • K823860 — NUCLIPASE (I125) PANCREATIC LIPASE (April 18, 1983)
  • K812794 — LIPASE (October 20, 1981)