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510(k) K772325

DENSITOMETER 18, COMPUTING, AUTO. by Gelman Instrument Co. — Product Code JQT

K772325 is an FDA 510(k) premarket notification submitted by Gelman Instrument Co. for the device "DENSITOMETER 18, COMPUTING, AUTO.". The FDA issued a decision of Substantially Equivalent on January 12, 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. Gelman Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1978
Date Received
December 19, 1977
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 Gelman Instrument Co.

  • K772076 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. (February 3, 1978)
  • K772080 — RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT (February 3, 1978)
  • K772074 — RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN (February 3, 1978)
  • K772079 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M (February 3, 1978)
  • K772073 — RADIAL IMMUNODIFFUSION KIT-COMP. 3 (February 3, 1978)
  • K772078 — RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN (February 3, 1978)
  • K772077 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G (February 3, 1978)
  • K772075 — RADIAL IMMUNODIFFUSION KIT-COMPLEMENT (February 3, 1978)
  • K771812 — LIPPOPROTEIN ELECTROPHORESIS REAGENT SET (October 18, 1977)
  • K770155 — ALKALINE PHOSPHATASE ISOYZME REAGENT SET (January 31, 1977)

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