Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALOCLAIR ORAL RINSE

K-Number: K023155 · 2002-11-25

ApplicantSinclair Pharmaceuticals, Ltd.
Decision Date2002-11-25
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

ALOCLAIR ORAL RINSE is the device name listed in this FDA 510(k) record. The listed applicant is Sinclair Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 2002-11-25 under 510(k) number K023155. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALOCLAIR ORAL RINSE?

ALOCLAIR ORAL RINSE is a medical device that received FDA 510(k) clearance on 2002-11-25. The listed applicant is Sinclair Pharmaceuticals, Ltd.. The 510(k) number is K023155.

When did ALOCLAIR ORAL RINSE receive FDA 510(k) clearance?

ALOCLAIR ORAL RINSE received FDA 510(k) clearance on 2002-11-25, under 510(k) number K023155.

Who is the listed applicant for ALOCLAIR ORAL RINSE?

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

What is the FDA product code for ALOCLAIR ORAL RINSE?

The FDA product code for ALOCLAIR ORAL RINSE is OLR.

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 Sinclair Pharmaceuticals, 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.

K050158SINCLAIR SEBORRHEA EMULSIONK042722ALOCLAIR ORAL SPRAYK040950ALOCLAIR ORAL GELK024148SALINUM, ORCLAIRK024367SINCLAIR WOUND AND SKIN EMULSIONK023046SST SALIVA SUPPORTING TABLETS

View all 8 devices →

Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

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.

↑