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510(k) K802396

GENERAL PROCEDURE AGAROSE FILM by Electrophoresis Corp. of America — Product Code JJN

K802396 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "GENERAL PROCEDURE AGAROSE FILM". The FDA issued a decision of Substantially Equivalent on November 26, 1980. The device falls under product code JJN (Apparatus, Electrophoresis, For Clinical Use), a Class I device regulated under 21 CFR 862.2485. Electrophoresis Corp. of America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1980
Date Received
October 2, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrophoresis, For Clinical Use
Device Class
Class I
Regulation Number
862.2485
Review Panel
CH
Submission Type

Other clearances by Electrophoresis Corp. of America

  • K792551 — ALKALINE PHOSPHATASE REAGENT (January 29, 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)
  • K791656 — ENZYME STABILIZING REAGENT (ESR) (September 17, 1979)
  • K791657 — LDH ISOENZYME REAGENT (September 17, 1979)

Other clearances for product code JJN

  • K924021 — POWER SUPPLY (January 28, 1993)
  • K924020 — ELECTROPHORESIS TANK (December 28, 1992)
  • K882344 — ELECTR-TRANSBLOTTER (January 13, 1989)
  • K881852 — REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 (July 8, 1988)
  • K882163 — HELENA REP GEL PROCESSOR (June 20, 1988)
  • K873352 — RAPID ELECTROPHORESIS SYSTEM (REP) (September 8, 1987)
  • K864436 — STAVIP 3000 (March 16, 1987)
  • K861414 — ELECTROPHORESIS WORK CENTER (EWC) (August 26, 1986)
  • K841407 — ISOGEL AGAROSE (July 16, 1985)
  • K844710 — EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (January 7, 1985)

FDA data resources