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510(k) K842313

ELVI 146 SEROSCAN by Logos Scientific, Inc. — Product Code JQT

K842313 is an FDA 510(k) premarket notification submitted by Logos Scientific, Inc. for the device "ELVI 146 SEROSCAN". The FDA issued a decision of Substantially Equivalent on September 10, 1984. The device falls under product code JQT (Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica), a Class I device regulated under 21 CFR 862.2400. Logos Scientific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1984
Date Received
June 12, 1984
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 Logos Scientific, Inc.

  • K902614 — ELVI 828 DIGICLOT MULTISCAN (November 8, 1990)
  • K843375 — ELVI 655 FLAME PHOTOMETER (May 20, 1985)
  • K844710 — EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (January 7, 1985)
  • K843296 — ELVI 675 DIGITRON (September 13, 1984)
  • K842056 — ELVI 165 PROTEO SEROSKOP (June 22, 1984)
  • K841804 — ELVI 70 SAFETY CHAMBER (May 31, 1984)
  • K840757 — ELVI 444 BILITRON (May 30, 1984)
  • K841288 — ELVI 18 (May 2, 1984)

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