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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Folic, Radioimmunoassay
510(k) Number K001266
Device Name VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Applicant Contact DARLENE PHILLIPS
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Correspondent Contact DARLENE PHILLIPS
Regulation Number862.1295
Classification Product Code
CGN  
Subsequent Product Code
JIS  
Date Received04/20/2000
Decision Date 05/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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