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FDA 510(k)

OCCULT BLOOD TEST

K-Number: K842137 · 1984-09-05

ApplicantBreit Laboratories, Inc.
Decision Date1984-09-05
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OCCULT BLOOD TEST is the device name listed in this FDA 510(k) record. The listed applicant is Breit Laboratories, Inc.. It received FDA 510(k) clearance on 1984-09-05 under 510(k) number K842137. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCCULT BLOOD TEST?

OCCULT BLOOD TEST is a medical device that received FDA 510(k) clearance on 1984-09-05. The listed applicant is Breit Laboratories, Inc.. The 510(k) number is K842137.

When did OCCULT BLOOD TEST receive FDA 510(k) clearance?

OCCULT BLOOD TEST received FDA 510(k) clearance on 1984-09-05, under 510(k) number K842137.

Who is the listed applicant for OCCULT BLOOD TEST?

The FDA 510(k) record lists Breit Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCCULT BLOOD TEST?

The FDA product code for OCCULT BLOOD TEST is KHE.

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Other records listing Breit Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K851099IGM RHEUMATOID FACTOR TEST KITK840527COLOTRAK OCCULT BLOOD TESTK832031ANTI-N DNA ANTIBODY TEST KITK831927ANTINUCLEAR ANTIBODY TEST KIT

Related Devices (Code: KHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestAlfa Scientific Designs, Inc.K170548InSure ONEEnterix, Inc.K171484hema-screen SPECIFIC GoldImmunostics Inc.,K162333Wondfo One Step Fecal Occult Blood (FOB) TestGuangzhou Wondfo Biotech Co., Ltd.K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestImmunostics Inc.,K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KITSEKISUI Diagnostics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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