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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K962166
Device Name ORIGEN ANALYZER
Applicant
Igen, Inc.
16020 Industrial Dr.
Gaithersburg,  MD  20877
Applicant Contact RICHARD PYTELEWSKI
Correspondent
Igen, Inc.
16020 Industrial Dr.
Gaithersburg,  MD  20877
Correspondent Contact RICHARD PYTELEWSKI
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/04/1996
Decision Date 07/31/1996
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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