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510(k) K952816

LIPASE FLEX REAGENT CARTRIDGE by Dupont Medical Products — Product Code CHI

K952816 is an FDA 510(k) premarket notification submitted by Dupont Medical Products for the device "LIPASE FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on July 20, 1995. The device falls under product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase), a Class I device regulated under 21 CFR 862.1465. Dupont Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1995
Date Received
June 20, 1995
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 Dupont Medical Products

  • K952815 — DUPONT LIPASE CALIBRATOR (August 31, 1995)
  • K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD (August 11, 1995)
  • K952412 — DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL (June 23, 1995)
  • K945280 — DUPONT DIMENSION C-REACTIVE PROTEIN METHOD (March 9, 1995)
  • K944932 — PHENOBARBITAL FLEX REAGENT CARTRIDGE (December 28, 1994)
  • K941050 — DUPONT ACA STAR (November 10, 1994)
  • K943996 — DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (October 20, 1994)
  • K941146 — DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM (October 3, 1994)
  • K942640 — DUPONT DIMENSION AMYLASE METHOD (September 9, 1994)
  • K942241 — DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN (August 18, 1994)

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)
  • 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