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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
510(k) Number K860501
Device Name FLAME PHOTOMETER STANDARD
Applicant
Medical Specialties, Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Applicant Contact RONALD DEVITA
Correspondent
Medical Specialties, Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Correspondent Contact RONALD DEVITA
Regulation Number862.1315
Classification Product Code
JLJ  
Date Received02/11/1986
Decision Date 04/07/1986
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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