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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 K934178
Device Name ACCUSCREEN 17-HYDROXYPROGESTERONE
Applicant
Neometrics, Inc.
104bellerose Ave.
E. Northport,  NY  11731
Applicant Contact DAVID SCHWARTZ
Correspondent
Neometrics, Inc.
104bellerose Ave.
E. Northport,  NY  11731
Correspondent Contact DAVID SCHWARTZ
Regulation Number862.1395
Classification Product Code
JLX  
Date Received08/27/1993
Decision Date 03/30/1995
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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