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510(k) K792550

PONCEAU S STAIN SET by Electrophoresis Corp. of America — Product Code KQC

K792550 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "PONCEAU S STAIN SET". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code KQC (Stains, Hematology), 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
January 16, 1980
Date Received
December 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Hematology
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)
  • K792553 — AGAROSE BARBITAL-EDTA BUFFER (January 29, 1980)
  • K792551 — ALKALINE PHOSPHATASE REAGENT (January 29, 1980)
  • K792547 — AGAROSE BARBITAL BUFFER (January 29, 1980)
  • K792548 — ALKALINE PHOSPHATASE MARKER (January 29, 1980)
  • K792574 — MOPSO BUFFER (January 21, 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)
  • K791655 — CPK ISOENZYME REAGENT (September 17, 1979)

Other clearances for product code KQC

  • K882873 — FIELDTEX HEMATOXYLIN (July 28, 1988)
  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K843619 — RETIC-SET (October 30, 1984)
  • K841848 — RETIC-SET (May 31, 1984)
  • K792496 — VOLU-SOL NMB RETICULOCYTE STAIN (December 31, 1979)
  • K791007 — STAT DIFF STAIN (August 3, 1979)
  • K760487 — HEMASTAIN PHOSPHATE BUFFER (August 30, 1976)
  • K760485 — HEMASTAIN FIXATIVE (August 30, 1976)

FDA data resources