COLOTRAK OCCULT BLOOD TEST— 510(k) K840527

Name: FDA 510(k) clearance K840527
Creator: U.S. Food and Drug Administration
Published: 1984-09-05

Substantially Equivalent

Breit Laboratories, Inc.

FDA 510(k) clearance K840527 for COLOTRAK OCCULT BLOOD TEST, Substantially Equivalent on 1984-09-05. Applicant: Breit Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Breit Laboratories, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1984-02-07
Decision date: 1984-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K832031 — ANTI-N DNA ANTIBODY TEST KIT1983-08-11
K831927 — ANTINUCLEAR ANTIBODY TEST KIT1983-07-18

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