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510(k) K960115

HICHEM BUN/UREA REAGENT KIT by Elan Pharma, Inc. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1996
Date Received
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Elan Pharma, Inc.

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  • K981769 — HICHEM PHOSPHORUS REAGENT KIT (June 29, 1998)
  • K962247 — HICHEM CK/NAC REAGENT KIT (August 15, 1996)

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  • K021385 — ATAC PAK BUN REAGENT (July 12, 2002)
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