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510(k) K791654

NORMAL CONTROL by Electrophoresis Corp. of America — Product Code JJY

K791654 is an FDA 510(k) premarket notification submitted by Electrophoresis Corp. of America for the device "NORMAL CONTROL". The FDA issued a decision of Substantially Equivalent on September 17, 1979. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. 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
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Electrophoresis Corp. of America

  • K802396 — GENERAL PROCEDURE AGAROSE FILM (November 26, 1980)
  • K792548 — ALKALINE PHOSPHATASE MARKER (January 29, 1980)
  • K792551 — ALKALINE PHOSPHATASE REAGENT (January 29, 1980)
  • K792547 — AGAROSE BARBITAL BUFFER (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)
  • K791656 — ENZYME STABILIZING REAGENT (ESR) (September 17, 1979)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources