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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K852450
Device Name LODE COAGULOMETER MODEL LC-6
Applicant
Lode Corp.
2121 Terry Ave.
Seattle,  WA  98121
Applicant Contact DAN ROPER
Correspondent
Lode Corp.
2121 Terry Ave.
Seattle,  WA  98121
Correspondent Contact DAN ROPER
Regulation Number864.5425
Classification Product Code
JPA  
Date Received06/10/1985
Decision Date 09/30/1985
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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