EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL— 510(k) K850431

Name: FDA 510(k) clearance K850431
Creator: U.S. Food and Drug Administration
Published: 1985-06-17

Substantially Equivalent

Nms Pharmaceuticals, Inc.

FDA 510(k) clearance K850431 for EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL, Substantially Equivalent on 1985-06-17. Applicant: Nms Pharmaceuticals, Inc.. Device class: 2.

Clearance details

Applicant: Nms Pharmaceuticals, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1985-02-04
Decision date: 1985-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHE

view all

K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test2018-02-15
K170548 — InSure ONE2017-10-05
K171484 — hema-screen SPECIFIC Gold2017-06-14
K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test2017-05-14
K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test2017-01-17

More clearances from Nms Pharmaceuticals, Inc.

view all

K861202 — TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS1987-01-09
K854236 — HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS1986-10-10
K860828 — FORETEL, COLOR OVULATION TEST1986-08-04
K853925 — QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA1985-12-02
K851445 — COLOR OVULATION TEST1985-07-29

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