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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K902877
Device Name TOTAL IRON FOR MANUAL/AUTOMATED
Applicant
Catachem, Inc.
P.O. Box 6216
70 Hawley Ave.
Bridgeport,  CT  06606
Applicant Contact LUIS P LEON
Correspondent
Catachem, Inc.
P.O. Box 6216
70 Hawley Ave.
Bridgeport,  CT  06606
Correspondent Contact LUIS P LEON
Regulation Number862.1410
Classification Product Code
JIY  
Date Received07/02/1990
Decision Date 07/27/1990
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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