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510(k) K854423

IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES by Dynatech Laboratories, Inc. — Product Code LIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1985
Date Received
November 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Microbiology, Diagnostic
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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