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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter (Beta, Gamma) For Clinical Use
510(k) Number K821494
Device Name RIA STAT 16
Applicant
E. R. Squibb & Sons, Inc.
40 W 57th St.
New York,  NY  10019
Correspondent
E. R. Squibb & Sons, Inc.
40 W 57th St.
New York,  NY  10019
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received05/18/1982
Decision Date 06/03/1982
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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