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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K873617
Device Name GEMSTAR II SYSTEM
Applicant
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Applicant Contact LABREC, PHD
Correspondent
Electro-Nucleonics Laboratories, Inc.
7101 Riverwood Dr.
Columbia,  MD  21046
Correspondent Contact LABREC, PHD
Regulation Number862.2160
Classification Product Code
JJE  
Date Received09/08/1987
Decision Date 10/19/1987
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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