RADIAS FERRITIN ENZYME IMMUNOASSAY— 510(k) K933314

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K933314 for RADIAS FERRITIN ENZYME IMMUNOASSAY, Substantially Equivalent on 1993-09-08. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code DEW
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1993-07-07
Decision date: 1993-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DEW

K050113 — TINA-QUANT IGG GEN.22005-02-08
K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.22004-03-10
K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT2001-03-15
K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD2000-01-18
K993281 — K-ASSAY IGG1999-11-09

More clearances from Bio-Rad

K171061 — MRSASelect II2017-12-28
K122187 — VRESELECT CULTURE MEDIUM2012-11-06
K103684 — VRESELECT CULTURE MEDIUM2011-10-21
K093678 — PLATELIA ASPERGILLUS EIA MODEL 627932011-01-13
K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS2010-10-29

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