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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K781659
Device Name ASSAY SYSTEM, GAMMAFLO, AUTOMATED
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
Date Received09/28/1978
Decision Date 10/24/1978
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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