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510(k) K760475

REAGENT, CALCIUM DETERMINATION by Simmler & Son, Inc. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1976
Date Received
August 17, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

Other clearances by Simmler & Son, Inc.

  • K780817 — GLOBIN-TERGE (July 27, 1978)
  • K771906 — PHOSPHATE (December 6, 1977)
  • K771904 — GLYCEROL KINASE (December 6, 1977)
  • K771903 — LIPASE (December 6, 1977)
  • K771905 — GLYCEROL SUBSTRATE (December 6, 1977)
  • K761086 — REAGENTS (January 12, 1977)
  • K760476 — REAGENT, LACTATE DEHYDROGENASE (November 1, 1976)
  • K760478 — REAGENT, BUN (UREA NITROGEN) DETERM. (October 29, 1976)
  • K760479 — REAGENT, TOTAL BILIRUBIN DETERMINATION (October 29, 1976)
  • K760477 — REAGENTS-4 FOR URIC ACID DETERMINATION (October 29, 1976)

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