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510(k) K983886

POCKIT HSV 2 RAPID TEST by Diagnology , Ltd. — Product Code LGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1999
Date Received
November 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

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  • K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM (September 29, 1998)
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