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510(k) K961179

SENTINEL LIPASE LIQUID MODEL 17.401B by Equal Diagnostics, Inc. — Product Code CHI

K961179 is an FDA 510(k) premarket notification submitted by Equal Diagnostics, Inc. for the device "SENTINEL LIPASE LIQUID MODEL 17.401B". The FDA issued a decision of Substantially Equivalent on July 19, 1996. The device falls under product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase), a Class I device regulated under 21 CFR 862.1465. Equal Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1996
Date Received
March 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase-Esterase, Enzymatic, Photometric, Lipase
Device Class
Class I
Regulation Number
862.1465
Review Panel
CH
Submission Type

Other clearances by Equal Diagnostics, Inc.

  • K981800 — SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 (July 6, 1998)

Other clearances for product code CHI

  • K970905 — SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT (June 4, 1997)
  • K952180 — CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS (August 17, 1995)
  • K952816 — LIPASE FLEX REAGENT CARTRIDGE (July 20, 1995)
  • K952647 — IL TEST LIPASE (July 20, 1995)
  • K941085 — LIPASE-PS ASSAY PROCEDURE NO. 805 (May 17, 1994)
  • K923917 — ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY (February 25, 1994)
  • K921249 — WAKO AUTOKIT LIPASE-COLOR (July 21, 1992)
  • K920337 — MILES LIPASE SERA-PAK METHOD (March 11, 1992)
  • K900827 — COLORIMETRIC CHLORIDE PRODUCT #4314125 (May 2, 1990)
  • K897150 — LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT (February 26, 1990)

FDA data resources