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FDA 510(k)

RESUBMITTED EBV/IGM-CHECK TEST KIT

K-Number: K890639 · 1989-06-20

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

Device Summary

RESUBMITTED EBV/IGM-CHECK 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 K890639. The device is classified under product code LJN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESUBMITTED EBV/IGM-CHECK TEST KIT?

RESUBMITTED EBV/IGM-CHECK 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 K890639.

When did RESUBMITTED EBV/IGM-CHECK TEST KIT receive FDA 510(k) clearance?

RESUBMITTED EBV/IGM-CHECK TEST KIT received FDA 510(k) clearance on 1989-06-20, under 510(k) number K890639.

Who is the listed applicant for RESUBMITTED EBV/IGM-CHECK 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 RESUBMITTED EBV/IGM-CHECK TEST KIT?

The FDA product code for RESUBMITTED EBV/IGM-CHECK TEST KIT is LJN.

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Other records listing Diagnostic Technology, Inc. as applicant

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K896378LYME-CHECK(TM) TEST KITK903612EBV/EA-CHECK TM TEST KITK890819HSV-CHECK(TM) TEST KITK891542EBNA-CHECK(TM) TEST KITK871373EBV-CHECK(TM) TEST KIT (IGG)K864128CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT

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Related Devices (Code: LJN)

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.

K123021BIOPLEX 2200 EBV IGM KITBio-Rad LaboratoriesK073381PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600MFocus Diagnostics, Inc.K042092ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEMZeus Scientific, Inc.K033780MODIFICATION TO SERAQUEST VCA IGMQuest Intl., Inc.K990977SERAQUEST EB VAC IGMQuest Intl., Inc.K991459COPALIS EBV-M ANTIBODY ASSAYDiaSorin, 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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