Device Classification Name |
dna probe, nucleic acid amplification, chlamydia |
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---|---|---|---|---|
510(k) Number | K110923 | |||
Device Name | COBAS 4800 CT / NG TEST | |||
Applicant |
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Applicant Contact | james bonds | |||
Correspondent |
|
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Correspodent Contact | james bonds | |||
Regulation Number | 866.3120 | |||
Classification Product Code |
|
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Subsequent Product Codes |
|
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Date Received | 04/01/2011 | |||
Decision Date | 01/24/2012 | |||
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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FDA Review | Decision Summary | |||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
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Recalls | CDRH Recalls |