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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 K820832
Device Name PHOSPHORUS IL
Applicant
American Monitor Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Monitor Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1520
Classification Product Code
CED  
Date Received03/26/1982
Decision Date 04/15/1982
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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