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510(k) K941624

RUBELLA IGG ELISA TEST by Gull Laboratories, Inc. — Product Code LFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1995
Date Received
April 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

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  • K922758 — HSV-1 IGM ELISA TEST -- MODIFICATION (October 5, 1992)
  • K922759 — HSV-2 IGM ELISA TEST--MODIFICATION (October 5, 1992)

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