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510(k) K902614

ELVI 828 DIGICLOT MULTISCAN by Logos Scientific, Inc. — Product Code KQG

K902614 is an FDA 510(k) premarket notification submitted by Logos Scientific, Inc. for the device "ELVI 828 DIGICLOT MULTISCAN". The FDA issued a decision of Substantially Equivalent on November 8, 1990. The device falls under product code KQG (Instrument, Coagulation), a Class II device regulated under 21 CFR 864.5400. Logos Scientific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1990
Date Received
June 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

Other clearances by Logos Scientific, Inc.

  • K843375 — ELVI 655 FLAME PHOTOMETER (May 20, 1985)
  • K844710 — EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (January 7, 1985)
  • K843296 — ELVI 675 DIGITRON (September 13, 1984)
  • K842313 — ELVI 146 SEROSCAN (September 10, 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 KQG

  • K050821 — COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM (August 16, 2005)
  • K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (October 25, 2002)
  • K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C (September 3, 1999)
  • K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200 (June 21, 1999)
  • K983475 — HEMOCHRON RESPONSE (May 3, 1999)
  • K900685 — CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER (April 16, 1990)
  • K862047 — COAGULATOR (8 CHANNEL) (September 29, 1986)
  • K852492 — COAGULATOR (August 13, 1985)
  • K851169 — ELECTRA 800 AUTOMATIC COAGULATION TIMER (June 24, 1985)
  • K823131 — KOAGULAB 40-A AUTOMATED COAGULATION SYS (December 9, 1982)

FDA data resources