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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Homocystine (Nonquantitative) Test System
510(k) Number K011689
Device Name HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
Applicant
Catch, Inc.
P.O. Box 2219
Longview,  WA  98632
Applicant Contact MARK E LEGAZ
Correspondent
Catch, Inc.
P.O. Box 2219
Longview,  WA  98632
Correspondent Contact MARK E LEGAZ
Regulation Number862.1377
Classification Product Code
LPS  
Date Received05/31/2001
Decision Date 07/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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