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510(k) K792551

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

K792551 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "ALKALINE PHOSPHATASE REAGENT". The FDA issued a decision of Substantially Equivalent on January 29, 1980. The device falls under product code CJH (Thymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Electrophoresis Corp. of America has at least 10 other 510(k) clearances on record.

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)
  • K792548 — ALKALINE PHOSPHATASE MARKER (January 29, 1980)
  • K792553 — AGAROSE BARBITAL-EDTA BUFFER (January 29, 1980)
  • K792547 — AGAROSE BARBITAL BUFFER (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)
  • K791656 — ENZYME STABILIZING REAGENT (ESR) (September 17, 1979)

FDA data resources