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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood, Occult, Colorimetric, In Urine
510(k) Number K921495
Device Name DIA STRIPS SYSTEM, MODIFIED
Applicant
Symcon Intl., Inc.
8270 Nieman Rd.
Lenexa,  KS  66214
Applicant Contact DAVID MORGAN
Correspondent
Symcon Intl., Inc.
8270 Nieman Rd.
Lenexa,  KS  66214
Correspondent Contact DAVID MORGAN
Regulation Number864.6550
Classification Product Code
JIO  
Date Received03/06/1992
Decision Date 07/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
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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