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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 K912026
Device Name DELFIA(R) 17 -OH-PROGESTERON KIT
Applicant
Pharmacia Diagnostics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Applicant Contact JUDITH J SMITH
Correspondent
Pharmacia Diagnostics, Inc.
8310 Guilford Rd.
Columbia,  MD  21046
Correspondent Contact JUDITH J SMITH
Regulation Number862.1395
Classification Product Code
JLX  
Date Received05/07/1991
Decision Date 06/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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