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FDA 510(k)

HSV-2 ELISA IGG, MODEL EL0920G

K-Number: K993724 · 2000-02-01

ApplicantMrl Diagnostics
Decision Date2000-02-01
Product CodeMYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV-2 ELISA IGG, MODEL EL0920G is the device name listed in this FDA 510(k) record. The listed applicant is Mrl Diagnostics. It received FDA 510(k) clearance on 2000-02-01 under 510(k) number K993724. The device is classified under product code MYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSV-2 ELISA IGG, MODEL EL0920G?

HSV-2 ELISA IGG, MODEL EL0920G is a medical device that received FDA 510(k) clearance on 2000-02-01. The listed applicant is Mrl Diagnostics. The 510(k) number is K993724.

When did HSV-2 ELISA IGG, MODEL EL0920G receive FDA 510(k) clearance?

HSV-2 ELISA IGG, MODEL EL0920G received FDA 510(k) clearance on 2000-02-01, under 510(k) number K993724.

Who is the listed applicant for HSV-2 ELISA IGG, MODEL EL0920G?

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

What is the FDA product code for HSV-2 ELISA IGG, MODEL EL0920G?

The FDA product code for HSV-2 ELISA IGG, MODEL EL0920G is MYF.

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Other records listing Mrl Diagnostics 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.

K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GK993754HSV-1 ELISA IGG, MODEL EL0910GK971007LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)K971006LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)K946353EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAYK931520EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY

View all 7 devices →

Related Devices (Code: MYF)

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.

K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsBiokit, S.A.K220924Elecsys HSV-2 IgG (08948887160)Roche DiagnosticsK181514SeraQuest HSV Type 2 Specific IgGQuest International, Inc.K181334ADVIA Centaur Herpes-2 IgGBiokit, S.A.K152353SeraQuest HSV Type 2 Specific IgGQuest International, Inc.K103603ZEUS ELISA HSV GG-2 IGG TEST SYSTEMZeus Scientific, 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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