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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ph Rate Measurement, Carbon-Dioxide
510(k) Number K963540
Device Name SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact WILLIAM R GILBERT
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact WILLIAM R GILBERT
Regulation Number862.1160
Classification Product Code
JFL  
Subsequent Product Codes
CEM   CGZ   JGS  
Date Received09/04/1996
Decision Date 09/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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