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FDA 510(k)

RESUBMITTED FECATWIN SENSITIVE - FECA-EIA

K-Number: K896474 · 1990-01-25

ApplicantLabsystems, Inc.
Decision Date1990-01-25
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED FECATWIN SENSITIVE - FECA-EIA is the device name listed in this FDA 510(k) record. The listed applicant is Labsystems, Inc.. It received FDA 510(k) clearance on 1990-01-25 under 510(k) number K896474. 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 RESUBMITTED FECATWIN SENSITIVE - FECA-EIA?

RESUBMITTED FECATWIN SENSITIVE - FECA-EIA is a medical device that received FDA 510(k) clearance on 1990-01-25. The listed applicant is Labsystems, Inc.. The 510(k) number is K896474.

When did RESUBMITTED FECATWIN SENSITIVE - FECA-EIA receive FDA 510(k) clearance?

RESUBMITTED FECATWIN SENSITIVE - FECA-EIA received FDA 510(k) clearance on 1990-01-25, under 510(k) number K896474.

Who is the listed applicant for RESUBMITTED FECATWIN SENSITIVE - FECA-EIA?

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

What is the FDA product code for RESUBMITTED FECATWIN SENSITIVE - FECA-EIA?

The FDA product code for RESUBMITTED FECATWIN SENSITIVE - FECA-EIA is KHE.

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Other records listing Labsystems, 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.

K923365TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEMK890154MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIAK890091MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KITK881243RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201K873780MODIFICATION RUBELLA IGM EIA TEST KITK873583AUTO-EIA

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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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