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510(k) K961204

MUMPS IGG TEST by Zeus Scientific, Inc. — Product Code LJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1996
Date Received
March 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Device Class
Class I
Regulation Number
866.3380
Review Panel
MI
Submission Type

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Other clearances for product code LJY

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