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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K840299
Device Name PH ELECTRODE CALIBRATING BUFFERS-BLOOD
Applicant
Bionostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Bionostics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIS  
Date Received01/24/1984
Decision Date 03/23/1984
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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