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510(k) K760786

ENZYMATIC LIPASE MAX-PACK REAGENT by Calbiochem — Product Code CHI

K760786 is an FDA 510(k) premarket notification submitted by Calbiochem for the device "ENZYMATIC LIPASE MAX-PACK REAGENT". The FDA issued a decision of Substantially Equivalent on January 6, 1977. The device falls under product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase), a Class I device regulated under 21 CFR 862.1465. Calbiochem has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1977
Date Received
October 6, 1976
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 Calbiochem

  • K771993 — AFT SYSTEM (November 2, 1977)
  • K760366 — REAGENT, Y-GT MAX-PACK (November 1, 1976)

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)
  • K952647 — IL TEST LIPASE (July 20, 1995)
  • K952816 — LIPASE FLEX REAGENT CARTRIDGE (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