Atlas FDA

SPAPLUS

FDA 510(k) clearance K100179 · decided 2010-08-13

Clearance details

K-number
K100179
Device name
SPAPLUS
Applicant
The Binding Site Group , Ltd.
Decision
Substantially Equivalent
Date received
2010-01-21
Decision date
2010-08-13
Days to decision
204 days
Clearance type
Traditional
Product code
CZW
Device class
2
Regulation number
866.5240
Medical specialty
Immunology
Advisory committee
Immunology
Location
Los Angele, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.