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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name 5-amp-phosphate release (colorimetric test), 5'-nucleotidase
510(k) Number K811864
Device Name SIGMA PROCEDURE 265-UV
Applicant
SIGMA CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SIGMA CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1520
Classification Product Code
CED  
Date Received07/01/1981
Decision Date 07/31/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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