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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tetraphenyl Borate, Colorimetry, Potassium
510(k) Number K904033
Device Name REFLOTRON POTASSIUM TEST TABS
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact JOHN STEVENS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact JOHN STEVENS
Regulation Number862.1600
Classification Product Code
CEJ  
Date Received08/31/1990
Decision Date 11/06/1990
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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