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FDA 510(k)

IMMUNOCCULT EIA TEST KIT

K-Number: K871143 · 1988-07-08

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1988-07-08
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUNOCCULT EIA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Immunoassay Laboratories, Inc.. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K871143. 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 IMMUNOCCULT EIA TEST KIT?

IMMUNOCCULT EIA TEST KIT is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K871143.

When did IMMUNOCCULT EIA TEST KIT receive FDA 510(k) clearance?

IMMUNOCCULT EIA TEST KIT received FDA 510(k) clearance on 1988-07-08, under 510(k) number K871143.

Who is the listed applicant for IMMUNOCCULT EIA TEST KIT?

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

What is the FDA product code for IMMUNOCCULT EIA TEST KIT?

The FDA product code for IMMUNOCCULT EIA TEST KIT is KHE.

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Other records listing Intl. Immunoassay 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.

K913380MYDAS(TM)-MB2/MYDAS(TM)-MBK913349STAMBI-CKK912231PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KITK903441MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTSK903508LABELLING CHANGES TO IMPRES-MB-XK901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB

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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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