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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, 17-Hydroxyprogesterone
510(k) Number K885198
Device Name 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA
Applicant
Icn Biomedicals, Inc.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Applicant Contact ROBERT HUDAK
Correspondent
Icn Biomedicals, Inc.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Correspondent Contact ROBERT HUDAK
Regulation Number862.1395
Classification Product Code
JLX  
Date Received12/16/1988
Decision Date 02/23/1989
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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