Home / 510(k) Clearances / K851154

510(k) K851154

ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 by Astral Medical Systems — Product Code JQT

K851154 is an FDA 510(k) premarket notification submitted by Astral Medical Systems for the device "ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18". The FDA issued a decision of Substantially Equivalent on May 13, 1985. The device falls under product code JQT (Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica), a Class I device regulated under 21 CFR 862.2400. Astral Medical Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1985
Date Received
March 22, 1985
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 Astral Medical Systems

  • K900506 — MODIFIED COATRON II AND COATRON JR. (March 12, 1990)
  • K851153 — COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE (November 5, 1985)
  • K853734 — APOLLO DENSITOMETER (September 25, 1985)

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)
  • K850617 — CORNING 780 FLUOROMETER/DENSITOMETER (March 12, 1985)
  • K850260 — GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER (February 27, 1985)
  • K842313 — ELVI 146 SEROSCAN (September 10, 1984)

FDA data resources