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510(k) K902918

SYNERMED SERUM IRON REAGENT KIT by Synermed, Inc. — Product Code CFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1990
Date Received
July 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bathophenanthroline, Colorimetry, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type

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  • K952179 — SYNERMED ISE REAGENTS (June 20, 1995)
  • K943924 — CREATININE-PO REAGENT KIT (September 20, 1994)
  • K941091 — SYNERMED AMYLASE REAGENT KIT (May 3, 1994)

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