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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spectrophotometric Method, Pregnanediol
510(k) Number K872843
Device Name OVEIA (TM) DUAL ANALYTE
Applicant
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Applicant Contact JOHN G SIMPSON
Correspondent
Boots-Celltech Diagnostics, Inc.
240 Bath Rd.
Slough Sl1 4et
Berkshire, England,  GB
Correspondent Contact JOHN G SIMPSON
Regulation Number862.1605
Classification Product Code
JLP  
Date Received07/20/1987
Decision Date 02/02/1988
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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