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510(k) K893718

DELTATEST (R) LIPASE II by Electro-Nucleonics, Inc. — Product Code CET

K893718 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics, Inc. for the device "DELTATEST (R) LIPASE II". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code CET (Olive Oil Emulsion (Turbidimetric), Lipase), a Class I device regulated under 21 CFR 862.1465. Electro-Nucleonics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
May 17, 1989
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 Electro-Nucleonics, Inc.

  • K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (April 28, 1989)
  • K883427 — VIRGO(R) VZV-IGG ELISA (March 10, 1989)
  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K883102 — VIRGO (R) CMV-IGG ELISA (February 8, 1989)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883205 — ALTLTS ALANINE AMINO TRANSFERASE ALT (September 9, 1988)
  • K883206 — LACTATE DEHYDROGENASE LDH (September 9, 1988)

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)
  • 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