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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bathophenanthroline, Colorimetry, Iron (Non-Heme)
510(k) Number K932871
Device Name UIBC FOR DISCREET RANDOM ACCESS ANALYZER
Applicant
Catachem, Inc.
70 Hawley Ave.
Bridgeport,  CT  06606
Applicant Contact LUIS LEON
Correspondent
Catachem, Inc.
70 Hawley Ave.
Bridgeport,  CT  06606
Correspondent Contact LUIS LEON
Regulation Number862.1410
Classification Product Code
CFM  
Date Received06/14/1993
Decision Date 09/08/1993
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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