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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 K861255
Device Name BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS
Applicant
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact JOHN E HUGHES
Correspondent
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact JOHN E HUGHES
Regulation Number862.1340
Classification Product Code
JIL  
Date Received04/03/1986
Decision Date 10/03/1986
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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