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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 K811222
Device Name INORGANIC PHOSPHORUS REAGENTS
Applicant
Connecticut Diagnostics, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Connecticut Diagnostics, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1520
Classification Product Code
CED  
Date Received05/04/1981
Decision Date 05/21/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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