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510(k) K771906

PHOSPHATE by Simmler & Son, Inc. — Product Code CDT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1977
Date Received
October 7, 1977
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 Simmler & Son, Inc.

  • K780817 — GLOBIN-TERGE (July 27, 1978)
  • K771904 — GLYCEROL KINASE (December 6, 1977)
  • K771905 — GLYCEROL SUBSTRATE (December 6, 1977)
  • K771903 — LIPASE (December 6, 1977)
  • K761086 — REAGENTS (January 12, 1977)
  • K760476 — REAGENT, LACTATE DEHYDROGENASE (November 1, 1976)
  • K760475 — REAGENT, CALCIUM DETERMINATION (October 29, 1976)
  • K760480 — REAGENT, TOTAL PROTEIN DETERMINATION (October 29, 1976)
  • K760474 — REAGENT, ALKALINE PHOSPHATASE DETERM. (October 29, 1976)
  • K760473 — REAGENT, ALBUMIN DETERMINATION (October 29, 1976)

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