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510(k) K984476

LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 by Bio-Rad — Product Code LKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1998
Date Received
December 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Rnp Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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  • K990624 — AUTOSTAT II ANTI-SM/RNP ELISA (April 28, 1999)
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