ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST— 510(k) K001900

Name: FDA 510(k) clearance K001900
Creator: U.S. Food and Drug Administration
Published: 2000-09-11

Substantially Equivalent

Helix Diagnostics, Inc.

FDA 510(k) clearance K001900 for ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST, Substantially Equivalent on 2000-09-11. Applicant: Helix Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Helix Diagnostics, Inc.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2000-06-22
Decision date: 2000-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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K040811 — VARELISA SSDNA ANTIBODIES, MODEL 148962004-05-13
K000477 — MDI DS-DNA TEST2000-03-01

More clearances from Helix Diagnostics, Inc.

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K000489 — ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST2000-04-05
K980337 — DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM1998-05-12
K960091 — ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT1996-03-20
K954700 — ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT1995-12-15
K954723 — ENZYME IMMUNOASSAY ANA SCREENING TEST KIT1995-12-15

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