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510(k) K062808

LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT by Catch Incorporated — Product Code LPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2006
Date Received
September 19, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Homocystine (Nonquantitative) Test System
Device Class
Class II
Regulation Number
862.1377
Review Panel
CH
Submission Type

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