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510(k) K792551

ALKALINE PHOSPHATASE REAGENT by Electrophoresis Corp. of America — Product Code CJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1980
Date Received
December 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes
Device Class
Class II
Regulation Number
862.1050
Review Panel
CH
Submission Type

Other clearances by Electrophoresis Corp. of America

  • K802396 — GENERAL PROCEDURE AGAROSE FILM (November 26, 1980)
  • K792547 — AGAROSE BARBITAL BUFFER (January 29, 1980)
  • K792553 — AGAROSE BARBITAL-EDTA BUFFER (January 29, 1980)
  • K792548 — ALKALINE PHOSPHATASE MARKER (January 29, 1980)
  • K792574 — MOPSO BUFFER (January 21, 1980)
  • K792550 — PONCEAU S STAIN SET (January 16, 1980)
  • K792552 — AMIDO BLACK 10B STAIN (December 18, 1979)
  • K792549 — FAT RED 7B STAIN SET (December 18, 1979)
  • K791655 — CPK ISOENZYME REAGENT (September 17, 1979)
  • K791654 — NORMAL CONTROL (September 17, 1979)