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)

ALLERGEAZE PATCH TEST CHAMBERS

K-Number: K063160 · 2006-12-22

ApplicantSmartpractice
Decision Date2006-12-22
Product CodeKXF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALLERGEAZE PATCH TEST CHAMBERS is the device name listed in this FDA 510(k) record. The listed applicant is Smartpractice. It received FDA 510(k) clearance on 2006-12-22 under 510(k) number K063160. The device is classified under product code KXF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLERGEAZE PATCH TEST CHAMBERS?

ALLERGEAZE PATCH TEST CHAMBERS is a medical device that received FDA 510(k) clearance on 2006-12-22. The listed applicant is Smartpractice. The 510(k) number is K063160.

When did ALLERGEAZE PATCH TEST CHAMBERS receive FDA 510(k) clearance?

ALLERGEAZE PATCH TEST CHAMBERS received FDA 510(k) clearance on 2006-12-22, under 510(k) number K063160.

Who is the listed applicant for ALLERGEAZE PATCH TEST CHAMBERS?

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

What is the FDA product code for ALLERGEAZE PATCH TEST CHAMBERS?

The FDA product code for ALLERGEAZE PATCH TEST CHAMBERS is KXF.

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 Smartpractice 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.

K123184FINN CHAMBERS AQUAK103409ALLERGEAZE R CLEARK023232SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE

Related Devices (Code: KXF)

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.

K123184FINN CHAMBERS AQUASmartpracticeK103409ALLERGEAZE R CLEARSmartpracticeK013820FINN CHAMBER (R)Epitest Ltd. OYK992553IQ CHAMBERSDormer Laboratories, Inc.K870762EAR APPLICATOR, CATALOG NO. 2229Treace Medical, Inc.K843720COTTON TIPPED APPLICATORS, SINGLEAbco Dealers, 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.

↑