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FDA 510(k)

CHLAMYDIA TRACHOMATIS ANTIGEN TEST

K-Number: K941714 · 1994-07-18

ApplicantNeogenex
Decision Date1994-07-18
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIA TRACHOMATIS ANTIGEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Neogenex. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K941714. The device is classified under product code LJP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLAMYDIA TRACHOMATIS ANTIGEN TEST?

CHLAMYDIA TRACHOMATIS ANTIGEN TEST is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Neogenex. The 510(k) number is K941714.

When did CHLAMYDIA TRACHOMATIS ANTIGEN TEST receive FDA 510(k) clearance?

CHLAMYDIA TRACHOMATIS ANTIGEN TEST received FDA 510(k) clearance on 1994-07-18, under 510(k) number K941714.

Who is the listed applicant for CHLAMYDIA TRACHOMATIS ANTIGEN TEST?

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

What is the FDA product code for CHLAMYDIA TRACHOMATIS ANTIGEN TEST?

The FDA product code for CHLAMYDIA TRACHOMATIS ANTIGEN TEST is LJP.

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Other records listing Neogenex 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.

K965047MINK LUNG CELL CULTUREK960909H292 CELL CULTUREK943886BGM CELL CULTUREK943890WI38 CELL CULTUREK943888MDCK CELL CULTUREK943887HUMAN NEWBORN FORESKIN CELL CULTURE

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Related Devices (Code: LJP)

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.

K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KITDiagnostic Hybrids, Inc.K901243CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TESTCel Labs Pty, Ltd.K900870PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TESTDiagnostic Products Corp.K895839PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1Diagnostic Products Corp.K883352FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTIWhittaker Bioproducts, Inc.K881500ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TESTOrtho Diagnostic Systems, 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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