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510(k) K781121

HEMOLYSE by Electrophoresis Corp. of America — Product Code GGK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1978
Date Received
July 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Red-Cell Lysing Products
Device Class
Class I
Regulation Number
864.8540
Review Panel
HE
Submission Type

Other clearances by Electrophoresis Corp. of America

  • K802396 — GENERAL PROCEDURE AGAROSE FILM (November 26, 1980)
  • K792548 — ALKALINE PHOSPHATASE MARKER (January 29, 1980)
  • K792547 — AGAROSE BARBITAL BUFFER (January 29, 1980)
  • K792553 — AGAROSE BARBITAL-EDTA BUFFER (January 29, 1980)
  • K792551 — ALKALINE PHOSPHATASE REAGENT (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)
  • K792552 — AMIDO BLACK 10B STAIN (December 18, 1979)
  • K791655 — CPK ISOENZYME REAGENT (September 17, 1979)

Other clearances for product code GGK

  • K883836 — COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II (November 30, 1988)
  • K883991 — KVM HEMOGLOBIN LYSING REAGENT (October 12, 1988)
  • K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (October 20, 1987)
  • K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (September 9, 1987)
  • K863114 — PIASTRINIT (November 6, 1986)
  • K863503 — HEMOLYSE (October 3, 1986)
  • K850944 — NSI LYSING-D REAGENT -4000 ML (March 29, 1985)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)