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510(k) K802842

SINGLE VIAL LIPASE TEST KIT by Biodynamics Corp. — Product Code CHI

K802842 is an FDA 510(k) premarket notification submitted by Biodynamics Corp. for the device "SINGLE VIAL LIPASE TEST KIT". The FDA issued a decision of Substantially Equivalent on December 18, 1980. The device falls under product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase), a Class I device regulated under 21 CFR 862.1465. Biodynamics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1980
Date Received
November 12, 1980
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 Biodynamics Corp.

  • K051675 — BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER (March 16, 2006)
  • K884033 — BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER (November 17, 1988)
  • K881631 — BIODYNAMICS AUTOTRANSFUSION RESERVOIR (September 9, 1988)
  • K881968 — BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER (July 28, 1988)
  • K874361 — BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER (March 16, 1988)
  • K873807 — AUTOTRANSFUSION APPARATUS (March 9, 1988)
  • K874034 — ADR-22 AUTOMATIC DIALYZER REPROCESSOR (October 23, 1987)
  • K870052 — INFUMIX MIXING CONTAINER (February 27, 1987)
  • K822716 — UNIVERSAL CENTRIFUGE (September 30, 1982)
  • K822715 — PLATELET CENTRIFUGE (September 30, 1982)

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