Device Classification Name |
susceptibility test discs, antimicrobial |
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---|---|---|---|---|
510(k) Number | K992077 | |||
Device Name | PASCO MIC AND MIC/ID PANELS (OFLOXACIN) | |||
Applicant |
|
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Applicant Contact | linda k dillon | |||
Correspondent |
|
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Correspodent Contact | linda k dillon | |||
Regulation Number | 866.1620 | |||
Classification Product Code |
|
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Date Received | 06/21/1999 | |||
Decision Date | 09/03/1999 | |||
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 |