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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 K861974
Device Name PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST
Applicant
Perceptive Systems, Inc.
1301 Regents Park Dr.
Houston,  TX  77058
Applicant Contact RICHARD TOMPKINS
Correspondent
Perceptive Systems, Inc.
1301 Regents Park Dr.
Houston,  TX  77058
Correspondent Contact RICHARD TOMPKINS
Regulation Number864.5260
Classification Product Code
LNJ  
Date Received05/21/1986
Decision Date 08/04/1986
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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