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510(k) K911233

CHAGAS' IGG ELISA TEST by Gull Laboratories, Inc. — Product Code MIU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1992
Date Received
March 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunosorbent Assay, T. Cruzi
Device Class
Class I
Regulation Number
866.3870
Review Panel
MI
Submission Type

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  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)

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