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FDA 510(k)

ALLERGEAZE R CLEAR

K-Number: K103409 · 2011-03-15

ApplicantSmartpractice
Decision Date2011-03-15
Product CodeKXF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALLERGEAZE R CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Smartpractice. It received FDA 510(k) clearance on 2011-03-15 under 510(k) number K103409. 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 R CLEAR?

ALLERGEAZE R CLEAR is a medical device that received FDA 510(k) clearance on 2011-03-15. The listed applicant is Smartpractice. The 510(k) number is K103409.

When did ALLERGEAZE R CLEAR receive FDA 510(k) clearance?

ALLERGEAZE R CLEAR received FDA 510(k) clearance on 2011-03-15, under 510(k) number K103409.

Who is the listed applicant for ALLERGEAZE R CLEAR?

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 R CLEAR?

The FDA product code for ALLERGEAZE R CLEAR 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.

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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 AQUAK063160ALLERGEAZE PATCH TEST CHAMBERSK023232SPLATRFREE 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 AQUASmartpracticeK063160ALLERGEAZE PATCH TEST CHAMBERSSmartpracticeK013820FINN 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.

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