RADIAS ANA SCREEN ENZYME IMMUNOASSAY— 510(k) K941509

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K941509 for RADIAS ANA SCREEN ENZYME IMMUNOASSAY, Substantially Equivalent on 1994-06-30. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1994-03-29
Decision date: 1994-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJM

K182353 — EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay2018-11-27
K151559 — ImmuLisa Enhanced Centromere Antibody ELISA2016-03-11
K140493 — ELIA SCL-70S IMMUNOASSAY2014-10-30
K123880 — QUANTA FLASH CENTROMERE2014-02-07
K131330 — GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT2014-01-28

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.