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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrolyte Controls (Assayed And Unassayed)
510(k) Number K834505
Device Name HUMAN SERUM ELECTROLYTE CONTROL-LIQUID
Applicant
Quantimetrix Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Quantimetrix Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1660
Classification Product Code
JJR  
Date Received12/21/1983
Decision Date 04/13/1984
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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