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510(k) K962198

QUANTEX C4 by Instrumentation Laboratory CO — Product Code DBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1996
Date Received
June 7, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C4, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

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Other clearances for product code DBI

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  • K981785 — C4 MININEPH ANTISERUM (December 20, 1999)
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