ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY— 510(k) K900241

Name: FDA 510(k) clearance K900241
Creator: U.S. Food and Drug Administration
Published: 1990-02-02

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K900241 for ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY, Substantially Equivalent on 1990-02-02. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1990-01-17
Decision date: 1990-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLL

view all

K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La2026-08-21
K253367 — EliA CTD 13 Screen2026-06-25
K250666 — Alegria Flash CTD Screen2025-10-22
K250408 — Alegria Flash ENA Screen2025-09-19
K213403 — Aptiva CTD Essential Reagent2023-09-29

More clearances from Diamedix Corp.

view all

K093101 — MAGO 4S2011-01-21
K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM2002-07-09
K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN2002-01-08
K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM2001-12-21
K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM2001-10-26

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