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510(k) K894011

TOTAL GALACTOSE by Alpkem Corp. — Product Code KQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
June 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Device Class
Class II
Regulation Number
862.1315
Review Panel
CH
Submission Type

Other clearances by Alpkem Corp.

  • K891070 — PHENYLALANINE (NINHYDRIN REACTION) (October 27, 1989)
  • K890334 — TOTAL CHOLESTEROL REAGENT (May 3, 1989)
  • K890337 — TRIGLYCERIDES - GPO REAGENT (March 9, 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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  • K993536 — BIO-RAD CODA NEONATAL GALT ASSAY (November 4, 1999)
  • K990827 — MICROPLATE NEONATAL GALT ASSAY (April 9, 1999)
  • K970277 — URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (December 11, 1997)