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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K926386
Device Name VISTA PROLACTIN ASSAY
Applicant
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact PAUL L ROGERS
Correspondent
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact PAUL L ROGERS
Regulation Number862.1625
Classification Product Code
CFT  
Date Received12/22/1992
Decision Date 03/29/1993
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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