OCCULT BLOOD TEST— 510(k) K842137

Substantially Equivalent

Breit Laboratories, Inc.

FDA 510(k) clearance K842137 for 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: 1984-05-30
Decision date: 1984-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Breit Laboratories, Inc.

K851099 — IGM RHEUMATOID FACTOR TEST KIT1985-04-25
K840527 — COLOTRAK OCCULT BLOOD TEST1984-09-05
K832031 — ANTI-N DNA ANTIBODY TEST KIT1983-08-11
K831927 — ANTINUCLEAR ANTIBODY TEST KIT1983-07-18

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