ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY— 510(k) K954829

Substantially Equivalent

Orgentec

FDA 510(k) clearance K954829 for ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY, Substantially Equivalent on 1996-04-18. Applicant: Orgentec. Device class: 2.

Clearance details

Applicant: Orgentec
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1995-10-20
Decision date: 1996-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, 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 Orgentec

K954830 — ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY1996-05-08
K954831 — ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY1996-05-08
K954814 — ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY1996-04-18
K954815 — ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY1996-04-18
K954832 — ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY1996-04-18

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