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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K873835
Device Name GLUCOSE-HK REAGENT
Applicant
Intersect Systems, Inc.
1606 E. Kessler Blvd., #100
P.O. Box 889
Longview,  WA  98632
Applicant Contact LESTER B GARRISON
Correspondent
Intersect Systems, Inc.
1606 E. Kessler Blvd., #100
P.O. Box 889
Longview,  WA  98632
Correspondent Contact LESTER B GARRISON
Regulation Number862.1345
Classification Product Code
CFR  
Date Received09/21/1987
Decision Date 11/24/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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