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FDA 510(k)

QUICK CULT SLIDE TEST FECAL OCCULT BLOOD

K-Number: K761232 · 1976-12-21

ApplicantLaboratory Diagnostics Co., Inc.
Decision Date1976-12-21
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUICK CULT SLIDE TEST FECAL OCCULT BLOOD is the device name listed in this FDA 510(k) record. The listed applicant is Laboratory Diagnostics Co., Inc.. It received FDA 510(k) clearance on 1976-12-21 under 510(k) number K761232. 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 QUICK CULT SLIDE TEST FECAL OCCULT BLOOD?

QUICK CULT SLIDE TEST FECAL OCCULT BLOOD is a medical device that received FDA 510(k) clearance on 1976-12-21. The listed applicant is Laboratory Diagnostics Co., Inc.. The 510(k) number is K761232.

When did QUICK CULT SLIDE TEST FECAL OCCULT BLOOD receive FDA 510(k) clearance?

QUICK CULT SLIDE TEST FECAL OCCULT BLOOD received FDA 510(k) clearance on 1976-12-21, under 510(k) number K761232.

Who is the listed applicant for QUICK CULT SLIDE TEST FECAL OCCULT BLOOD?

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

What is the FDA product code for QUICK CULT SLIDE TEST FECAL OCCULT BLOOD?

The FDA product code for QUICK CULT SLIDE TEST FECAL OCCULT BLOOD is KHE.

Related Clinical Trials

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Other records listing Laboratory Diagnostics Co., 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.

K801668QUICK CEPT

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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