HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD— 510(k) K881907

Name: FDA 510(k) clearance K881907
Creator: U.S. Food and Drug Administration
Published: 1988-07-08

Substantially Equivalent

Enzo Biochem, Inc.

FDA 510(k) clearance K881907 for HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD, Substantially Equivalent on 1988-07-08. Applicant: Enzo Biochem, Inc.. Device class: 2.

Clearance details

Applicant: Enzo Biochem, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1988-05-06
Decision date: 1988-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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 Enzo Biochem, Inc.

view all

K880604 — COLORGENE HSV DNA HYBRIDIZATION TEST1988-08-03
K875367 — COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV1988-03-28
K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION1987-12-04
K870733 — COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.1987-05-26

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