PLATELIA ASPERGILLUS EIA MODEL 62793— 510(k) K093678

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K093678 for PLATELIA ASPERGILLUS EIA MODEL 62793, Substantially Equivalent on 2011-01-13. Applicant: Bio-Rad. Device class: 1.

Clearance details

Applicant: Bio-Rad
Product code: Code NOM
Device class: Class 1
Regulation: 21 CFR 866.3040
Advisory panel: Microbiology
Date received: 2009-11-27
Decision date: 2011-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NOM

K243496 — MycoMEIA Aspergillus Assay2025-08-01
K060641 — PLATELIA ASPERGILLUS EIA, MODEL 627932006-06-02
K023857 — PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 627942003-05-16

More clearances from Bio-Rad

K171061 — MRSASelect II2017-12-28
K122187 — VRESELECT CULTURE MEDIUM2012-11-06
K103684 — VRESELECT CULTURE MEDIUM2011-10-21
K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS2010-10-29
K081362 — PLATELIA LYME IGM2008-06-26

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