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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Atomic Absorption, Calcium
510(k) Number K871903
Device Name QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL)
Applicant
Creative Scientific Technology, Inc.
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Applicant Contact AKERKAR, PH.D.
Correspondent
Creative Scientific Technology, Inc.
55 Northern Blvd.
Suite 205
Great Neck,  NY  11021
Correspondent Contact AKERKAR, PH.D.
Regulation Number862.1145
Classification Product Code
JFN  
Date Received05/15/1987
Decision Date 09/02/1987
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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