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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Quinidine
510(k) Number K922913
Device Name EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
Applicant
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Applicant Contact ROGERS, JR.
Correspondent
Syva Co.
3403 Yerba Buena Rd.
P.O. Box 49013
San Jose,  CA  95161
Correspondent Contact ROGERS, JR.
Regulation Number862.3320
Classification Product Code
LBZ  
Date Received06/17/1992
Decision Date 08/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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