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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 K864862
Device Name REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.
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 Received12/11/1986
Decision Date 02/20/1987
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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