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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Calcium
510(k) Number K880973
Device Name MICROLYTE 7
Applicant
The Rupp & Bowman Co.
9206 Royal Ln.
Irving,  TX  75063
Applicant Contact SAMIR SHAMMAS
Correspondent
The Rupp & Bowman Co.
9206 Royal Ln.
Irving,  TX  75063
Correspondent Contact SAMIR SHAMMAS
Regulation Number862.1145
Classification Product Code
JFP  
Date Received03/08/1988
Decision Date 09/07/1988
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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