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510(k) K042641

CHEMVIEW-10 by Cenogenics Corp. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2005
Date Received
September 27, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

Other clearances by Cenogenics Corp.

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  • K894793 — MONODEX (August 21, 1989)
  • K843680 — URI-VAL (March 29, 1985)

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