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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
510(k) Number K802037
Device Name VITAMIN B12 FOLATE RADIOASSAY
Applicant
CORNING MEDICAL & SCIENTIFIC
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CORNING MEDICAL & SCIENTIFIC
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.2300
Classification Product Code
CCN  
Date Received08/22/1980
Decision Date 11/21/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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