IS-ANTI-SM TEST SYSTEM— 510(k) K970220

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K970220 for IS-ANTI-SM TEST SYSTEM, Substantially Equivalent on 1997-04-08. 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: 1997-01-21
Decision date: 1997-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K970220

K-number listed on FDA's recall record

Z-0445-2013 — The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.Class II·Terminated·Diamedix Corporation·20120806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970220.

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