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FDA 510(k)

EBNA STAT TEST KIT

K-Number: K911473 · 1991-09-25

ApplicantWhittaker Bioproducts, Inc.
Decision Date1991-09-25
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBNA STAT TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K911473. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBNA STAT TEST KIT?

EBNA STAT TEST KIT is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K911473.

When did EBNA STAT TEST KIT receive FDA 510(k) clearance?

EBNA STAT TEST KIT received FDA 510(k) clearance on 1991-09-25, under 510(k) number K911473.

Who is the listed applicant for EBNA STAT TEST KIT?

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

What is the FDA product code for EBNA STAT TEST KIT?

The FDA product code for EBNA STAT TEST KIT is LLM.

Other records listing Whittaker Bioproducts, 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.

K911356LEGIONELLA STAT IGG/IGM TEST KITK9132123M IGE SINGLE POINT FAST TESTK904652LYME STAT M TEST KITK904893FIAX LYME M TEST KITK904738PYLORI STAT TEST KITK905468PYLORI-G FIAX TEST KIT

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Related Devices (Code: LLM)

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.

K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSDiaSorin, Inc.K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K973941IMMUNOWELL EBNA IGG TESTGenbioK980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, Inc.

Official Source

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

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