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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 K842873
Device Name STANDARDS & ACCESSORIES FOR NOVA INSTRU
Applicant
Diagnostic Chemicals, Ltd. (Usa)
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1665
Classification Product Code
JGS  
Date Received07/23/1984
Decision Date 10/05/1984
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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