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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 K940233
Device Name NEOSCREEN ELISA HYDROXYPROGESTERONE
Applicant
Pantex
1737 21st St.
Santa Monica,  CA  90404
Applicant Contact NANCY CHOW
Correspondent
Pantex
1737 21st St.
Santa Monica,  CA  90404
Correspondent Contact NANCY CHOW
Regulation Number862.1395
Classification Product Code
JLX  
Date Received01/18/1994
Decision Date 12/28/1994
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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