Device Classification Name |
nitrophenylphosphate, alkaline phosphatase or isoenzymes |
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510(k) Number | K991762 | ||||
Device Name | ALKALINE PHOPHATASE (ALP), PRODUCT NO’S 118-01, 118-02 | ||||
Applicant |
|
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Applicant Contact | luis p leon | ||||
Correspondent |
|
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Correspodent Contact | luis p leon | ||||
Regulation Number | 862.1050 | ||||
Classification Product Code |
|
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Date Received | 05/24/1999 | ||||
Decision Date | 09/02/1999 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Clinical Chemistry |
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510k Review Panel |
Clinical Chemistry |
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statement |
statement |
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Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |