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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation, Automated
510(k) Number K921465
Device Name CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
Applicant
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Applicant Contact PAT FRANKS
Correspondent
Helena Laboratories
1530 Lindbergh Dr.
P.O. Box 752
Beaumont,  TX  77704
Correspondent Contact PAT FRANKS
Regulation Number864.5400
Classification Product Code
GKP  
Date Received03/27/1992
Decision Date 06/29/1992
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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