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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 K864849
Device Name ANTEK 703C CHEMILUMINESCENT NITROGEN ANALYZER
Applicant
Antek Instruments, Inc.
6005 N. Fwy.
Houston,  TX  77076
Applicant Contact JO MARTIN
Correspondent
Antek Instruments, Inc.
6005 N. Fwy.
Houston,  TX  77076
Correspondent Contact JO MARTIN
Regulation Number862.2160
Classification Product Code
JJE  
Date Received12/10/1986
Decision Date 08/28/1987
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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