Iron (Total) Assay Catalogue No. 102-10, 102-25

• • Terminated Z-1327-2009 FDA Unclassified (pre-2012) ·initiated 14 Mar 2008

  Precipitate in product may cause elevated background absorbance interference.

510(k) Number

K961587 ↗

FDA Product Code

JMO

FDA applicant

Diagnostic Chemicals , Ltd.

Device Class

Class I

Regulation

21 CFR Part 862.1415

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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