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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 K851820
Device Name SPINAL FLUID CONTROL
Applicant
Irvine Scientific
2511 Daimler St.
Santa Ana,  CA  92705
Applicant Contact ERNEST S JOHNSON
Correspondent
Irvine Scientific
2511 Daimler St.
Santa Ana,  CA  92705
Correspondent Contact ERNEST S JOHNSON
Regulation Number862.1660
Classification Product Code
JJY  
Date Received04/26/1985
Decision Date 07/15/1985
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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