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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K834387
Device Name YD STRIP GPH U21
Applicant
Yd Pharmaceutical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Yd Pharmaceutical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1340
Classification Product Code
JIL  
Date Received12/14/1983
Decision Date 05/14/1984
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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