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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K832020
Device Name HEMOCUE PHOTOMETER TECHNICAL MANUAL
Applicant
Aktiebolaget Leo Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Aktiebolaget Leo Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.5620
Classification Product Code
GKR  
Date Received06/15/1983
Decision Date 10/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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