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FDA 510(k)

HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G

K-Number: K000238 · 2000-04-14

ApplicantMrl Diagnostics
Decision Date2000-04-14
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G is the device name listed in this FDA 510(k) record. The listed applicant is Mrl Diagnostics. It received FDA 510(k) clearance on 2000-04-14 under 510(k) number K000238. The device is classified under product code LGC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G?

HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is Mrl Diagnostics. The 510(k) number is K000238.

When did HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G receive FDA 510(k) clearance?

HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G received FDA 510(k) clearance on 2000-04-14, under 510(k) number K000238.

Who is the listed applicant for HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G?

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-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G?

The FDA product code for HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G is LGC.

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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.

K993754HSV-1 ELISA IGG, MODEL EL0910GK993724HSV-2 ELISA IGG, MODEL EL0920GK971007LYME 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

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Related Devices (Code: LGC)

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.

K033059HERPES GROUP IGGTrinity Biotech, Inc.K010878MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6Diagnostic Products Corp.K002262DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEMDiamedix Corp.K992166THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K983886POCKIT HSV 2 RAPID TESTDiagnology , Ltd.K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTMeridian Diagnostics, 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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