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FDA 510(k)

ABBOTT HSV EIA

K-Number: K843622 · 1985-05-20

ApplicantAbbott Laboratories
Decision Date1985-05-20
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ABBOTT HSV EIA is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1985-05-20 under 510(k) number K843622. 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 ABBOTT HSV EIA?

ABBOTT HSV EIA is a medical device that received FDA 510(k) clearance on 1985-05-20. The listed applicant is Abbott Laboratories. The 510(k) number is K843622.

When did ABBOTT HSV EIA receive FDA 510(k) clearance?

ABBOTT HSV EIA received FDA 510(k) clearance on 1985-05-20, under 510(k) number K843622.

Who is the listed applicant for ABBOTT HSV EIA?

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

What is the FDA product code for ABBOTT HSV EIA?

The FDA product code for ABBOTT HSV EIA is LGC.

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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.K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GMrl DiagnosticsK992166THE 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.

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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