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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K922139
Device Name VISTA IMMUNOASSAY SYSTEM -- MODIFICATION
Applicant
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact ROGERS, JR.
Correspondent
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact ROGERS, JR.
Regulation Number862.2160
Classification Product Code
JJE  
Date Received04/16/1992
Decision Date 07/21/1992
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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