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510(k) K791654

NORMAL CONTROL by Electrophoresis Corp. of America — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1979
Date Received
August 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Electrophoresis Corp. of America

  • K802396 — GENERAL PROCEDURE AGAROSE FILM (November 26, 1980)
  • K792553 — AGAROSE BARBITAL-EDTA BUFFER (January 29, 1980)
  • K792547 — AGAROSE BARBITAL BUFFER (January 29, 1980)
  • K792548 — ALKALINE PHOSPHATASE MARKER (January 29, 1980)
  • K792551 — ALKALINE PHOSPHATASE REAGENT (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)

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