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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
Predetermined Change
Control Plan Authorized		 No
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