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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 K820594
Device Name BIOSTRIP G
Applicant
Helena Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Helena Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1340
Classification Product Code
JIL  
Date Received03/04/1982
Decision Date 05/05/1982
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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