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510(k) K853484

INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT by Biotech Research Laboratories, Inc. — Product Code GNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1986
Date Received
August 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Epstein-Barr Virus
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Biotech Research Laboratories, Inc.

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