Home / 510(k) Clearances / K781898

510(k) K781898

CLEARING SOLUTION #ECA01976 by Electrophoresis Corp. of America — Product Code JQK

K781898 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "CLEARING SOLUTION #ECA01976". The FDA issued a decision of Substantially Equivalent on December 20, 1978. The device falls under product code JQK (Immunodiffusion, Protein Fractionation), a Class I device regulated under 21 CFR 862.1630. Electrophoresis Corp. of America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1978
Date Received
November 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunodiffusion, Protein Fractionation
Device Class
Class I
Regulation Number
862.1630
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)
  • 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)
  • K791656 — ENZYME STABILIZING REAGENT (ESR) (September 17, 1979)

FDA data resources