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510(k) K792552

AMIDO BLACK 10B STAIN by Electrophoresis Corp. of America — Product Code HZZ

K792552 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "AMIDO BLACK 10B STAIN". The FDA issued a decision of Substantially Equivalent on December 18, 1979. The device falls under product code HZZ (Sudan Black B), a Class I device regulated under 21 CFR 864.1850. Electrophoresis Corp. of America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1979
Date Received
December 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sudan Black B
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Electrophoresis Corp. of America

  • K802396 — GENERAL PROCEDURE AGAROSE FILM (November 26, 1980)
  • K792548 — ALKALINE PHOSPHATASE MARKER (January 29, 1980)
  • K792551 — ALKALINE PHOSPHATASE REAGENT (January 29, 1980)
  • K792547 — AGAROSE BARBITAL BUFFER (January 29, 1980)
  • K792553 — AGAROSE BARBITAL-EDTA BUFFER (January 29, 1980)
  • K792574 — MOPSO BUFFER (January 21, 1980)
  • K792550 — PONCEAU S STAIN SET (January 16, 1980)
  • K792549 — FAT RED 7B STAIN SET (December 18, 1979)
  • K791656 — ENZYME STABILIZING REAGENT (ESR) (September 17, 1979)
  • K791655 — CPK ISOENZYME REAGENT (September 17, 1979)

Other clearances for product code HZZ

  • K843684 — SIGMA SUDAN BLACK REAGENT 380-1 (October 31, 1984)

FDA data resources