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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Calibrator, Secondary
510(k) Number K791312
Device Name CATALOG #4-2520 CHLORIDOMETER CHLORIDE
Applicant
Buchler Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Buchler Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1150
Classification Product Code
JIT  
Date Received07/11/1979
Decision Date 08/16/1979
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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