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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chromosome, Automated
510(k) Number K912085
Device Name ACLAIMS-IS
Applicant
W-Technology
2508 Garfield Ave.
Suite A
Carmichael,  CA  95608
Applicant Contact ROGER WELBORN
Correspondent
W-Technology
2508 Garfield Ave.
Suite A
Carmichael,  CA  95608
Correspondent Contact ROGER WELBORN
Regulation Number864.5260
Classification Product Code
LNJ  
Date Received05/13/1991
Decision Date 10/31/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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