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FDA 510(k)

DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST

K-Number: K851635 · 1985-10-10

ApplicantDiagnon Corp.
Decision Date1985-10-10
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnon Corp.. It received FDA 510(k) clearance on 1985-10-10 under 510(k) number K851635. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST?

DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST is a medical device that received FDA 510(k) clearance on 1985-10-10. The listed applicant is Diagnon Corp.. The 510(k) number is K851635.

When did DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST receive FDA 510(k) clearance?

DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST received FDA 510(k) clearance on 1985-10-10, under 510(k) number K851635.

Who is the listed applicant for DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST?

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

What is the FDA product code for DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST?

The FDA product code for DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST is GQL.

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 Diagnon 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.

K860967VIRTRAN VIRAL TRANSPORTER (MODIFIED)K851377DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RAK851378VIRTRAN VIRAL TRANPORTERK841302DIAGNON FOLATE 125I RIA KITK832717DIAGNON B12 57CO RIA KIT

Related Devices (Code: GQL)

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.

K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore CorporationK984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated 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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