Device Classification Name |
antigen, cf (including cf controls), respiratory syncytial virus |
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---|---|---|---|---|
510(k) Number | K021687 | |||
Device Name | BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK | |||
Original Applicant |
|
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Original Contact | anne jepson | |||
Regulation Number | 866.3480 | |||
Classification Product Code |
|
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Date Received | 05/22/2002 | |||
Decision Date | 09/13/2002 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Microbiology |
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510k Review Panel |
Microbiology |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |