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FDA 510(k)

IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY

K-Number: K914953 · 1992-02-19

ApplicantStellar Bio Systems, Inc.
Decision Date1992-02-19
Product CodeLKI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Stellar Bio Systems, Inc.. It received FDA 510(k) clearance on 1992-02-19 under 510(k) number K914953. The device is classified under product code LKI. It was reviewed by the MI advisory panel. Product code LKI falls under the category of Chemistry, which covers automated chemistry analyzers and related reagents. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY?

IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY is a medical device that received FDA 510(k) clearance on 1992-02-19. The listed applicant is Stellar Bio Systems, Inc.. The 510(k) number is K914953.

When did IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY receive FDA 510(k) clearance?

IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY received FDA 510(k) clearance on 1992-02-19, under 510(k) number K914953.

Who is the listed applicant for IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY?

The FDA 510(k) record lists Stellar Bio Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY?

The FDA product code for IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY is LKI. This falls under the Chemistry category.

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Other records listing Stellar Bio Systems, Inc. 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.

K992587EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMK990916INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODYK990915INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODYK905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1K900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.K882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)

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Related Devices (Code: LKI)

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.

K905531LUPUS(LE)-LATEX TESTImmco Diagnostics, Inc.K894625CHLAMYDIA (LGV-1)Bion Ent., Ltd.K883776BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDEBtc Corp.K854615MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TESSerono Diagnostics, Inc.K830342CULUTURE SET CHLAMYDIA ISOLATION ANDImmulok, 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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