Home / 510(k) Clearances / K982238

510(k) K982238

BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522 by Binax, Inc. — Product Code MJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1998
Date Received
June 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Legionella, Spp., Elisa
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

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  • K911356 — LEGIONELLA STAT IGG/IGM TEST KIT (July 30, 1992)