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510(k) K100179

SPAPLUS by The Binding Site Group , Ltd. — Product Code CZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2010
Date Received
January 21, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

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  • K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMA (October 19, 2004)
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  • K012361 — TINA-QUANT COMPLEMENT C3C TEST SYSTEM (November 29, 2001)
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  • K000469 — RANDOX COMPLEMENT C3 (March 27, 2000)
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