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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K970778
Device Name LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
Applicant
More Diagnostics
2216 Sunset Dr.
Los Osos,  CA  93402
Applicant Contact JAMES W SNIPES
Correspondent
More Diagnostics
2216 Sunset Dr.
Los Osos,  CA  93402
Correspondent Contact JAMES W SNIPES
Regulation Number862.1660
Classification Product Code
JJX  
Date Received03/04/1997
Decision Date 04/17/1997
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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