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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Red-Cell Lysing Products
510(k) Number K883991
Device Name KVM HEMOGLOBIN LYSING REAGENT
Applicant
Kvm Technologies, Inc.
9431 Roark Rd.
Houston,  TX  77099
Applicant Contact MOOSSY, JR
Correspondent
Kvm Technologies, Inc.
9431 Roark Rd.
Houston,  TX  77099
Correspondent Contact MOOSSY, JR
Regulation Number864.8540
Classification Product Code
GGK  
Date Received09/20/1988
Decision Date 10/12/1988
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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