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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 K813310
Device Name NO-HOIL COMBOSTAT II KIT
Applicant
Ria Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ria Products, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1810
Classification Product Code
CDD  
Date Received11/24/1981
Decision Date 12/17/1981
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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