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FDA 510(k)

POCKIT HSV 2 RAPID TEST

K-Number: K983886 · 1999-08-19

ApplicantDiagnology , Ltd.
Decision Date1999-08-19
Product CodeLGC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

POCKIT HSV 2 RAPID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnology , Ltd.. It received FDA 510(k) clearance on 1999-08-19 under 510(k) number K983886. 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 POCKIT HSV 2 RAPID TEST?

POCKIT HSV 2 RAPID TEST is a medical device that received FDA 510(k) clearance on 1999-08-19. The listed applicant is Diagnology , Ltd.. The 510(k) number is K983886.

When did POCKIT HSV 2 RAPID TEST receive FDA 510(k) clearance?

POCKIT HSV 2 RAPID TEST received FDA 510(k) clearance on 1999-08-19, under 510(k) number K983886.

Who is the listed applicant for POCKIT HSV 2 RAPID TEST?

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

What is the FDA product code for POCKIT HSV 2 RAPID TEST?

The FDA product code for POCKIT HSV 2 RAPID TEST 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.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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