Device Classification Name |
mixture, hematology quality control |
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---|---|---|---|---|---|
510(k) Number | K960471 | ||||
Device Name | TRI-COUNT 20 | ||||
Applicant |
|
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Applicant Contact | james d lapicola | ||||
Correspondent |
|
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Correspodent Contact | james d lapicola | ||||
Regulation Number | 864.8625 | ||||
Classification Product Code |
|
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Date Received | 02/01/1996 | ||||
Decision Date | 03/20/1996 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Hematology |
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510k Review Panel |
Hematology |
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Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |