Atlas FDA

JJA

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Radio-Labeled Iron Method, Iron (Non-Heme)
Device class
Class I (low risk)
Regulation
21 CFR 862.1410
Medical specialty
Clinical Chemistry
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RecordFirmDate
SIMUL-FER SERUM IRON TEST KIT (K820253)Diagnostic Reagents, Inc.1982-05-12
DIAGNOSTIC KIT, FERRITAB-FE-59 (K782159)Leeco Diagnostics, Inc.1979-02-01
IRON 59 KIT (K781769)Ria Products, Inc.1978-12-04
KIT, RADIOASSAY, SERUM IRON (K760045)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-07-20

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Every clearance here is in the API, with alerts when new ones post.