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510(k) K780817

GLOBIN-TERGE by Simmler & Son, Inc.

K780817 is an FDA 510(k) premarket notification submitted by Simmler & Son, Inc. for the device "GLOBIN-TERGE". The FDA issued a decision of Substantially Equivalent on July 27, 1978. Simmler & Son, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
May 18, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Simmler & Son, Inc.

  • K771904 — GLYCEROL KINASE (December 6, 1977)
  • K771905 — GLYCEROL SUBSTRATE (December 6, 1977)
  • K771906 — PHOSPHATE (December 6, 1977)
  • K771903 — LIPASE (December 6, 1977)
  • K761086 — REAGENTS (January 12, 1977)
  • K760476 — REAGENT, LACTATE DEHYDROGENASE (November 1, 1976)
  • K760479 — REAGENT, TOTAL BILIRUBIN DETERMINATION (October 29, 1976)
  • K760480 — REAGENT, TOTAL PROTEIN DETERMINATION (October 29, 1976)
  • K760477 — REAGENTS-4 FOR URIC ACID DETERMINATION (October 29, 1976)
  • K760474 — REAGENT, ALKALINE PHOSPHATASE DETERM. (October 29, 1976)

FDA data resources