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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K915233
Device Name MYOGLOBIN RIA TEST KIT
Applicant
Pro Diagnostics, Inc.
11320 S. Post Oak #204
Houston,  TX  77035
Applicant Contact ALI KHAN
Correspondent
Pro Diagnostics, Inc.
11320 S. Post Oak #204
Houston,  TX  77035
Correspondent Contact ALI KHAN
Regulation Number866.5680
Classification Product Code
DDR  
Date Received11/22/1991
Decision Date 03/30/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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