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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flame Emission Photometer For Clinical Use
510(k) Number K832886
Device Name FLAME PHOTOMETER T281-T282-T283
Applicant
Texas Intl. Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Texas Intl. Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2540
Classification Product Code
JJO  
Date Received08/26/1983
Decision Date 12/08/1983
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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