Device Classification Name |
antinuclear antibody, indirect immunofluorescent, antigen, control |
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510(k) Number | K024231 | |||
Device Name | LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 | |||
Original Applicant |
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Original Contact | yvette lloyd | |||
Regulation Number | 866.5100 | |||
Classification Product Code |
|
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Date Received | 12/23/2002 | |||
Decision Date | 01/13/2003 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Immunology |
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510k Review Panel |
Immunology |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |