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510(k) K853734

APOLLO DENSITOMETER by Astral Medical Systems — Product Code JQT

K853734 is an FDA 510(k) premarket notification submitted by Astral Medical Systems for the device "APOLLO DENSITOMETER". The FDA issued a decision of Substantially Equivalent on September 25, 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
September 25, 1985
Date Received
September 6, 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)
  • K851154 — ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 (May 13, 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)
  • 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)
  • K842313 — ELVI 146 SEROSCAN (September 10, 1984)

FDA data resources