Device Classification Name |
susceptibility test discs, antimicrobial |
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---|---|---|---|---|
510(k) Number | K000271 | |||
Device Name | HARDYDISK, SULFA/TRIMETH | |||
Original Applicant |
|
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Original Contact | melissa m traylor | |||
Regulation Number | 866.1620 | |||
Classification Product Code |
|
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Date Received | 01/28/2000 | |||
Decision Date | 04/07/2000 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Microbiology |
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510k Review Panel |
Microbiology |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |