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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Vitamin B12
510(k) Number K853127
Device Name MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL)
Applicant
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Applicant Contact JOHN M KAUFFMAN
Correspondent
Micromedic Systems
102 Witmer Rd.
Horsham,  PA  19044
Correspondent Contact JOHN M KAUFFMAN
Regulation Number862.1810
Classification Product Code
CDD  
Date Received07/25/1985
Decision Date 09/16/1985
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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