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510(k) K902614

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

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

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  • K842056 — ELVI 165 PROTEO SEROSKOP (June 22, 1984)
  • K841804 — ELVI 70 SAFETY CHAMBER (May 31, 1984)
  • K840757 — ELVI 444 BILITRON (May 30, 1984)
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  • K851169 — ELECTRA 800 AUTOMATIC COAGULATION TIMER (June 24, 1985)
  • K823131 — KOAGULAB 40-A AUTOMATED COAGULATION SYS (December 9, 1982)