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510(k) K790796

LIPASE REAGENT SET by Alta Diagnostics, Inc. — Product Code CET

K790796 is an FDA 510(k) premarket notification submitted by Alta Diagnostics, Inc. for the device "LIPASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on July 17, 1979. The device falls under product code CET (Olive Oil Emulsion (Turbidimetric), Lipase), a Class I device regulated under 21 CFR 862.1465. Alta Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1979
Date Received
April 24, 1979
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 Alta Diagnostics, Inc.

  • K800327 — MAGNESIUM REAGENT (March 25, 1980)
  • K792545 — URIC ACID KIT (January 29, 1980)
  • K792546 — FETAL CHECK (December 18, 1979)
  • K790797 — AMYLASE REAGENT SET (July 17, 1979)

Other clearances for product code CET

  • K970124 — LIPASE REAGENT SET (COLIPASE METHOD) (March 6, 1997)
  • K940457 — LIPASE REAGENT SYSTEM (June 2, 1994)
  • 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)

FDA data resources