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510(k) K980639

SERAQUEST ANTI-SSB by Quest Intl., Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1998
Date Received
February 19, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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  • K990977 — SERAQUEST EB VAC IGM (October 6, 1999)
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