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FDA 510(k)

CHLAMYDIA (LGV-1)

K-Number: K894625 · 1989-08-15

ApplicantBion Ent., Ltd.
Decision Date1989-08-15
Product CodeLKI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIA (LGV-1) is the device name listed in this FDA 510(k) record. The listed applicant is Bion Ent., Ltd.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K894625. 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 CHLAMYDIA (LGV-1)?

CHLAMYDIA (LGV-1) is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K894625.

When did CHLAMYDIA (LGV-1) receive FDA 510(k) clearance?

CHLAMYDIA (LGV-1) received FDA 510(k) clearance on 1989-08-15, under 510(k) number K894625.

Who is the listed applicant for CHLAMYDIA (LGV-1)?

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

What is the FDA product code for CHLAMYDIA (LGV-1)?

The FDA product code for CHLAMYDIA (LGV-1) is LKI. This falls under the Chemistry category.

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Other records listing Bion Ent., Ltd. 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.

K926066BION MUMPS-G ANTIBODY TEST SYSTEMK901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEK894622VARICELLA ZOSTER VIRUSK894623RESPIRATORY SYNCYTIAL VIRUSK894624MUMPS VIRUSK894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN

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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.

K914953IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODYStellar Bio Systems, Inc.K905531LUPUS(LE)-LATEX TESTImmco Diagnostics, Inc.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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