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510(k) K897150

LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT by Toyo Jozo Co., Ltd. — Product Code CHI

K897150 is an FDA 510(k) premarket notification submitted by Toyo Jozo Co., Ltd. for the device "LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT". The FDA issued a decision of Substantially Equivalent on February 26, 1990. The device falls under product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase), a Class I device regulated under 21 CFR 862.1465.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1990
Date Received
December 26, 1989
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 for product code CHI

  • K970905 — SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT (June 4, 1997)
  • K961179 — SENTINEL LIPASE LIQUID MODEL 17.401B (July 19, 1996)
  • 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)

FDA data resources