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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K851942
Device Name COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY
Applicant
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Correspondent Contact RICHARDSON-JONES
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/03/1985
Decision Date 05/31/1985
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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