Atlas FDA

BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

FDA 510(k) clearance K982238 · decided 1998-08-21

Clearance details

K-number
K982238
Device name
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
Applicant
Binax, Inc.
Decision
Substantially Equivalent
Date received
1998-06-25
Decision date
1998-08-21
Days to decision
57 days
Clearance type
Traditional
Product code
MJH
Device class
2
Regulation number
866.3300
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Portland, ME, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code recall (Z-0222-2007)Inverness Medical Professional Diagnostics2006-11-29