Device Classification Name |
c-reactive protein, antigen, antiserum, and control |
|||
---|---|---|---|---|
510(k) Number | K991224 | |||
Device Name | K-ASSAY CRP | |||
Applicant |
|
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Applicant Contact | colin getty | |||
Correspondent |
|
|||
Correspodent Contact | colin getty | |||
Regulation Number | 866.5270 | |||
Classification Product Code |
|
|||
Date Received | 04/12/1999 | |||
Decision Date | 05/14/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Immunology |
|||
510k Review Panel |
Immunology |
|||
statement |
statement |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |