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510(k) K940457

LIPASE REAGENT SYSTEM by Medical Diagnostic Technologies, Inc. — Product Code CET

K940457 is an FDA 510(k) premarket notification submitted by Medical Diagnostic Technologies, Inc. for the device "LIPASE REAGENT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 2, 1994. The device falls under product code CET (Olive Oil Emulsion (Turbidimetric), Lipase), a Class I device regulated under 21 CFR 862.1465. Medical Diagnostic Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1994
Date Received
February 1, 1994
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 Medical Diagnostic Technologies, Inc.

  • K062229 — CTC WORKSTATION, MODEL 2200 (September 11, 2006)
  • K972209 — SPECTROLYSE HEPARIN (ANTI-IIA) (August 12, 1997)
  • K963106 — CHROMOLIZE PAI-1 KIT (November 18, 1996)
  • K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA) (August 14, 1996)
  • K962489 — CHROMOLIZE TPA ASSAY KIT (July 31, 1996)
  • K960438 — TINTELIZE PAI-1 KIT (June 5, 1996)
  • K961724 — U-DOA CONTROLS (June 3, 1996)
  • K961370 — LA POSITIVE CONTROL PLASMA (May 24, 1996)
  • K955115 — VENOM TIEM REAGENT (April 3, 1996)
  • K955738 — BIOCLOT PROTEIN S (February 29, 1996)

Other clearances for product code CET

  • K970124 — LIPASE REAGENT SET (COLIPASE METHOD) (March 6, 1997)
  • K915706 — LIPASE REAGENT SET (February 18, 1992)
  • 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)

FDA data resources