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510(k) K780901

AUTOMATED ELECTROPHORESIS SYSTEM by Olympus Corp. — Product Code JQT

K780901 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "AUTOMATED ELECTROPHORESIS SYSTEM". The FDA issued a decision of Substantially Equivalent on June 28, 1978. The device falls under product code JQT (Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica), a Class I device regulated under 21 CFR 862.2400. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1978
Date Received
June 1, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class
Class I
Regulation Number
862.2400
Review Panel
CH
Submission Type

Other clearances by Olympus Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (November 30, 1994)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)

Other clearances for product code JQT

  • K111356 — ASIMANAGER - AT (November 9, 2011)
  • K944185 — ISOSCAN (November 17, 1994)
  • K915332 — MODEL 795 FLUOROMETER/DENSITOMETER (February 18, 1992)
  • K885254 — TARGET READER (January 27, 1989)
  • K860645 — ELECTROPHORESIS DATA CENTER (EDC) (December 17, 1986)
  • K862956 — ICON READER (August 19, 1986)
  • K853734 — APOLLO DENSITOMETER (September 25, 1985)
  • K851154 — ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 (May 13, 1985)
  • K850617 — CORNING 780 FLUOROMETER/DENSITOMETER (March 12, 1985)
  • K850260 — GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER (February 27, 1985)

FDA data resources