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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K905600
Device Name TECHLYTE ELECTROLYTE ANALYZER
Applicant
Technalysis, Inc.
1805 Rutherford Ln.
Austin,  TX  78754
Applicant Contact STEPHEN C BIBY
Correspondent
Technalysis, Inc.
1805 Rutherford Ln.
Austin,  TX  78754
Correspondent Contact STEPHEN C BIBY
Regulation Number862.1665
Classification Product Code
JGS  
Date Received12/14/1990
Decision Date 01/15/1991
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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