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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cyanomethemoglobin
510(k) Number K883992
Device Name KVM PREPACK HEMATOLOGY REAGENT SET
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 Number864.7500
Classification Product Code
GKK  
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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