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FDA 510(k)

PYLO-PLUS

K-Number: K052708 · 2006-05-01

ApplicantArj Medical, Inc.
Decision Date2006-05-01
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PYLO-PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Arj Medical, Inc.. It received FDA 510(k) clearance on 2006-05-01 under 510(k) number K052708. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PYLO-PLUS?

PYLO-PLUS is a medical device that received FDA 510(k) clearance on 2006-05-01. The listed applicant is Arj Medical, Inc.. The 510(k) number is K052708.

When did PYLO-PLUS receive FDA 510(k) clearance?

PYLO-PLUS received FDA 510(k) clearance on 2006-05-01, under 510(k) number K052708.

Who is the listed applicant for PYLO-PLUS?

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

What is the FDA product code for PYLO-PLUS?

The FDA product code for PYLO-PLUS is LYR.

Other records listing Arj Medical, Inc. 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.

K091472URITEST 50 AND URITEST 500 URINE ANALYZERK052719URITEST 10 URINALYSIS REAGENT STRIPS

Related Devices (Code: LYR)

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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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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