LPIA-FERRITIN ASSAY— 510(k) K924186

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K924186 for LPIA-FERRITIN ASSAY, Substantially Equivalent on 1992-12-23. Applicant: Seradyn, Inc.. Device class: 1.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code DEF
Device class: Class 1
Regulation: 21 CFR 866.5425
Advisory panel: Immunology
Date received: 1992-08-20
Decision date: 1992-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

More clearances from Seradyn, Inc.

K070645 — SERADYN QMS TOPIRAMATE2007-05-17
K062966 — QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS2007-01-12
K062204 — ARCHITECT CORTISOL ASSAY2006-09-22
K060998 — QMS TOBRAMYCIN2006-07-21
K060709 — MULTIGENT GENTAMICIN2006-06-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.