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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator/data processing module, for clinical use
510(k) Number K881194
Device Name RIA-QUICK
Applicant
QUANTITATIVE TECHNOLOGIES, INC.
40 UPTON RD.
P.O. BOX 1245
westboro,  MA  01581
Applicant Contact m broverman
Correspondent
QUANTITATIVE TECHNOLOGIES, INC.
40 UPTON RD.
P.O. BOX 1245
westboro,  MA  01581
Correspondent Contact m broverman
Regulation Number862.2100
Classification Product Code
JQP  
Date Received03/21/1988
Decision Date 06/01/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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