Atlas FDA

C-Reactive Protein Kit for use on SPAPLUS

FDA 510(k) clearance K161982 · decided 2017-04-05

Clearance details

K-number
K161982
Device name
C-Reactive Protein Kit for use on SPAPLUS
Applicant
The Binding Site Group
Decision
Substantially Equivalent
Date received
2016-07-19
Decision date
2017-04-05
Days to decision
260 days
Clearance type
Traditional
Product code
DCN
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Birmingham, GB
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018 recall (Z-1619-2020)The Binding Site Group, Ltd.2020-03-31