Device Classification Name |
colorimetry, cholinesterase |
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---|---|---|---|---|
510(k) Number | K023992 | |||
Device Name | WIENER LAB COLINESTERASA AA | |||
Original Applicant |
|
|||
Original Contact | viviana cetola | |||
Regulation Number | 862.3240 | |||
Classification Product Code |
|
|||
Date Received | 12/02/2002 | |||
Decision Date | 02/12/2003 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Toxicology |
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510k Review Panel |
Clinical Chemistry |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |