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510(k) K900827

COLORIMETRIC CHLORIDE PRODUCT #4314125 by American Research Products Co. — Product Code CHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1990
Date Received
February 21, 1990
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

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  • K900977 — AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 (April 11, 1990)

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  • 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)
  • K897150 — LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT (February 26, 1990)