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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Heparin
510(k) Number K834024
Device Name HEPARINOMETER
Applicant
Western Laboratories Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Western Laboratories Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.7525
Classification Product Code
KFF  
Date Received11/22/1983
Decision Date 06/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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