FE-CULT PLUS— 510(k) K811752

Substantially Equivalent

Gamma Biologicals, Inc.

FDA 510(k) clearance K811752 for FE-CULT PLUS, Substantially Equivalent on 1981-11-02. Applicant: Gamma Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Gamma Biologicals, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1981-06-22
Decision date: 1981-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHE

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 Gamma Biologicals, Inc.

K864207 — DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO1986-12-03
K861016 — GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS1986-04-18
K832473 — GAMMA SLIDE TEST FOR PREGNANCY1983-08-16
K820647 — GAMMA FETAL BLEED SCREENING TEST1982-05-12
K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION1982-03-04

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