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FDA 510(k)

BIOTEST ANTI-EBV RECOMBINANT, EA IGM

K-Number: K983842 · 1999-06-09

ApplicantBiotest Diagnostics Corp.
Decision Date1999-06-09
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOTEST ANTI-EBV RECOMBINANT, EA IGM is the device name listed in this FDA 510(k) record. The listed applicant is Biotest Diagnostics Corp.. It received FDA 510(k) clearance on 1999-06-09 under 510(k) number K983842. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEST ANTI-EBV RECOMBINANT, EA IGM?

BIOTEST ANTI-EBV RECOMBINANT, EA IGM is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Biotest Diagnostics Corp.. The 510(k) number is K983842.

When did BIOTEST ANTI-EBV RECOMBINANT, EA IGM receive FDA 510(k) clearance?

BIOTEST ANTI-EBV RECOMBINANT, EA IGM received FDA 510(k) clearance on 1999-06-09, under 510(k) number K983842.

Who is the listed applicant for BIOTEST ANTI-EBV RECOMBINANT, EA IGM?

The FDA 510(k) record lists Biotest Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOTEST ANTI-EBV RECOMBINANT, EA IGM?

The FDA product code for BIOTEST ANTI-EBV RECOMBINANT, EA IGM is LSE.

Related Clinical Trials

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.

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Other records listing Biotest Diagnostics Corp. 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.

K991650CMV BRITE TURBO KITK983839BIOTEST ANTI-EBV RECOMBINANTK983841BIOTEST ANTI-EBV RECOMBINANT, EBNA IGGK951550CMV BRITE ANTIGENEMIA TEST KIT

Related Devices (Code: LSE)

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.

K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, 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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