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510(k) K781122

LIPOPROTEIN STAIN by Electrophoresis Corp. of America — Product Code HZG

K781122 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "LIPOPROTEIN STAIN". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code HZG (Oil Red O), 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
August 31, 1978
Date Received
July 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oil Red O
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)
  • K792551 — ALKALINE PHOSPHATASE REAGENT (January 29, 1980)
  • K792548 — ALKALINE PHOSPHATASE MARKER (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)
  • K792552 — AMIDO BLACK 10B STAIN (December 18, 1979)
  • K792549 — FAT RED 7B STAIN SET (December 18, 1979)
  • K791656 — ENZYME STABILIZING REAGENT (ESR) (September 17, 1979)

FDA data resources