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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrators, drug specific
510(k) Number K871394
Device Name THEOPHYLLINE FPIA CALIBRATORS
Applicant
SIGMA DIAGNOSTICS, INC.
P.O. BOX 14508
st. louis,  MO  63178
Applicant Contact dennis murray
Correspondent
SIGMA DIAGNOSTICS, INC.
P.O. BOX 14508
st. louis,  MO  63178
Correspondent Contact dennis murray
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received04/07/1987
Decision Date 06/01/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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