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510(k) K791656

ENZYME STABILIZING REAGENT (ESR) by Electrophoresis Corp. of America — Product Code CFE

K791656 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "ENZYME STABILIZING REAGENT (ESR)". The FDA issued a decision of Substantially Equivalent on September 17, 1979. The device falls under product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Electrophoresis Corp. of America has at least 10 other 510(k) clearances on record.

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
Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class
Class II
Regulation Number
862.1445
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)
  • K792551 — ALKALINE PHOSPHATASE REAGENT (January 29, 1980)
  • K792548 — ALKALINE PHOSPHATASE MARKER (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)
  • K791655 — CPK ISOENZYME REAGENT (September 17, 1979)

Other clearances for product code CFE

  • K100307 — GELSCAN, MODEL 1206 (August 31, 2010)
  • K022455 — SPIFE LD-12 KIT, MODEL 3338 (October 1, 2002)
  • K020467 — SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 (March 29, 2002)
  • K970477 — HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT (March 10, 1997)
  • K940224 — CARDIO REP LD (August 17, 1994)
  • K921455 — ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD (April 29, 1992)
  • K905861 — ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH (February 6, 1991)
  • K894081 — ROCHO ISOMUNE - LD (August 31, 1989)
  • K892818 — REP(TM) LD-2 STAT KIT, CAT. NO. 3078 (June 20, 1989)
  • K874142 — TITAN GEL REP LDH-30 HV (November 24, 1987)

FDA data resources