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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, Sodium
510(k) Number K882801
Device Name RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.
Applicant
Hf Scientific, Inc.
3052 Metro Pkwy. SE
Ft. Myers,  FL  33916
Applicant Contact BARBARA H SNEADE
Correspondent
Hf Scientific, Inc.
3052 Metro Pkwy. SE
Ft. Myers,  FL  33916
Correspondent Contact BARBARA H SNEADE
Regulation Number862.1665
Classification Product Code
JGS  
Date Received07/07/1988
Decision Date 08/29/1988
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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