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FDA 510(k)

EBNA-CHECK(TM) TEST KIT

K-Number: K891542 · 1989-06-20

ApplicantDiagnostic Technology, Inc.
Decision Date1989-06-20
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBNA-CHECK(TM) TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Technology, Inc.. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K891542. 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-CHECK(TM) TEST KIT?

EBNA-CHECK(TM) TEST KIT is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Diagnostic Technology, Inc.. The 510(k) number is K891542.

When did EBNA-CHECK(TM) TEST KIT receive FDA 510(k) clearance?

EBNA-CHECK(TM) TEST KIT received FDA 510(k) clearance on 1989-06-20, under 510(k) number K891542.

Who is the listed applicant for EBNA-CHECK(TM) TEST KIT?

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

What is the FDA product code for EBNA-CHECK(TM) TEST KIT?

The FDA product code for EBNA-CHECK(TM) TEST KIT is LLM.

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Other records listing Diagnostic Technology, 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.

K896378LYME-CHECK(TM) TEST KITK903612EBV/EA-CHECK TM TEST KITK890639RESUBMITTED EBV/IGM-CHECK TEST KITK890819HSV-CHECK(TM) TEST KITK871373EBV-CHECK(TM) TEST KIT (IGG)K864128CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. 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

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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