ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM— 510(k) K093837

Name: FDA 510(k) clearance K093837
Creator: U.S. Food and Drug Administration
Published: 2010-10-01

Substantially Equivalent

Zeus Scientific, Inc. (Zeus)

FDA 510(k) clearance K093837 for ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM, Substantially Equivalent on 2010-10-01. Applicant: Zeus Scientific, Inc. (Zeus). Device class: 2.

Clearance details

Applicant: Zeus Scientific, Inc. (Zeus)
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2009-12-15
Decision date: 2010-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIP

view all

K241427 — Access Syphilis2024-09-06
K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack2024-08-28
K211302 — Elecsys Syphilis2021-07-20
K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set2017-05-11
K160910 — Elecsys Syphilis2016-07-28

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