AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1— 510(k) K030849

Name: FDA 510(k) clearance K030849
Creator: U.S. Food and Drug Administration
Published: 2004-02-02

Substantially Equivalent

N-Dia, Inc.

FDA 510(k) clearance K030849 for AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1, Substantially Equivalent on 2004-02-02. Applicant: N-Dia, Inc.. Device class: 1.

Clearance details

Applicant: N-Dia, Inc.
Product code: Code JJX
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2003-03-17
Decision date: 2004-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJX

view all

K170678 — Beta-CrossLaps CalCheck 52017-04-04
K162173 — Elecsys CYFRA 21-1 CalCheck 52017-01-12
K162514 — Multichem A1c2016-10-26
K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose2016-08-10
K161522 — LIAISON EBV IgM Serum Control Set2016-06-30

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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