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FDA 510(k)

IDEIA(TM) CHLAMYDIA, MODIFICATION

K-Number: K911430 · 1991-08-07

ApplicantNovo Nordisk Diagnostics, Ltd.
Decision Date1991-08-07
Product CodeLIC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDEIA(TM) CHLAMYDIA, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Novo Nordisk Diagnostics, Ltd.. It received FDA 510(k) clearance on 1991-08-07 under 510(k) number K911430. The device is classified under product code LIC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDEIA(TM) CHLAMYDIA, MODIFICATION?

IDEIA(TM) CHLAMYDIA, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-08-07. The listed applicant is Novo Nordisk Diagnostics, Ltd.. The 510(k) number is K911430.

When did IDEIA(TM) CHLAMYDIA, MODIFICATION receive FDA 510(k) clearance?

IDEIA(TM) CHLAMYDIA, MODIFICATION received FDA 510(k) clearance on 1991-08-07, under 510(k) number K911430.

Who is the listed applicant for IDEIA(TM) CHLAMYDIA, MODIFICATION?

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

What is the FDA product code for IDEIA(TM) CHLAMYDIA, MODIFICATION?

The FDA product code for IDEIA(TM) CHLAMYDIA, MODIFICATION is LIC.

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 Novo Nordisk Diagnostics, 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.

K901972ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA

Related Devices (Code: LIC)

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.

K921075PHADEBACT MONOCLONAL GC TEST, MODIFICATIONKaro Bio Diagnostics ABK880076G-MARKBainbridge Laboratories, Inc.K874078MERITEC(TM)-GCMeridian Diagnostics, Inc.K871105THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAENew Horizons Diagnostics Co.K851650PHADEBACT MONOCLONAL GC OMNI TESTPharmacia, Inc.K850351PHADEBACT MONOCLONAL GC TESTPharmacia, 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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