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FDA 510(k)

IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT

K-Number: K882674 · 1989-08-15

ApplicantIcn Immunobiologicals
Decision Date1989-08-15
Product CodeLKH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Icn Immunobiologicals. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K882674. The device is classified under product code LKH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT?

IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Icn Immunobiologicals. The 510(k) number is K882674.

When did IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT receive FDA 510(k) clearance?

IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT received FDA 510(k) clearance on 1989-08-15, under 510(k) number K882674.

Who is the listed applicant for IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT?

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

What is the FDA product code for IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT?

The FDA product code for IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT is LKH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Icn Immunobiologicals 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.

K882369ACCRAASSAY RID KITS

Related Devices (Code: LKH)

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.

K910644IPAZYME (TM) CHLAMYDIA IGG-IGASavyon Diagnostics , Ltd.K901975IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)Savyon Diagnostics , Ltd.K893669CELLMATICS SHLAMYDIA DETECTION SYSTEMDifco Laboratories, Inc.K852869SELECTICULT-CHLAMYDIAScott Laboratories, Inc.K842151CHLAMYDIAE IMMUNOPEROXIDASE TEST KITBartels Immunodiagnostic Supplies, Inc.K830688COMBION SKIN TESTNicholas H. Maganias

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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