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510(k) K890337

TRIGLYCERIDES - GPO REAGENT by Alpkem Corp. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Alpkem Corp.

  • K894011 — TOTAL GALACTOSE (January 11, 1990)
  • K891070 — PHENYLALANINE (NINHYDRIN REACTION) (October 27, 1989)
  • K890334 — TOTAL CHOLESTEROL REAGENT (May 3, 1989)
  • K890336 — GLUCOSE (GOD) REAGENT (February 27, 1989)
  • K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (February 17, 1989)
  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
  • K890333 — ALBUMIN REAGENT (February 17, 1989)
  • K883020 — RFA-300 RAPID FLOW ANALYZER W/COMPUTER (September 2, 1988)
  • K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (April 11, 1986)
  • K851990 — INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU (June 25, 1985)

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