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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K830569
Device Name CYNOX I HEMOGLOBINOMETER
Applicant
Buffalo Medical Specialties Mfg., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Buffalo Medical Specialties Mfg., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received02/22/1983
Decision Date 04/08/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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