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510(k) K925209

MUMPS STAT by Biowhittaker Molecular Applications, Inc. — Product Code LJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1994
Date Received
October 7, 1992
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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  • K923903 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA (August 9, 1993)
  • K897006 — PHARMACIA MUMPS IGG ELISA (July 26, 1990)
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