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FDA 510(k)

XYLENE SUBSTITUTE

K-Number: K853694 · 1985-10-22

ApplicantLerner Laboratories, Inc.
Decision Date1985-10-22
Product CodeKEM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

XYLENE SUBSTITUTE is the device name listed in this FDA 510(k) record. The listed applicant is Lerner Laboratories, Inc.. It received FDA 510(k) clearance on 1985-10-22 under 510(k) number K853694. The device is classified under product code KEM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XYLENE SUBSTITUTE?

XYLENE SUBSTITUTE is a medical device that received FDA 510(k) clearance on 1985-10-22. The listed applicant is Lerner Laboratories, Inc.. The 510(k) number is K853694.

When did XYLENE SUBSTITUTE receive FDA 510(k) clearance?

XYLENE SUBSTITUTE received FDA 510(k) clearance on 1985-10-22, under 510(k) number K853694.

Who is the listed applicant for XYLENE SUBSTITUTE?

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

What is the FDA product code for XYLENE SUBSTITUTE?

The FDA product code for XYLENE SUBSTITUTE is KEM.

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 Lerner Laboratories, 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.

K854083XYLENE SUBSTITUTE MONTANTK821443FORMICALK761000PAP-TRAY I (CATALOG #C600-1)K761001PAP-TRAY II (CATALOG #C600-2)

Related Devices (Code: KEM)

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.

K881282XYLENEAnatech, Ltd.K874461HEMO-SOLChem Pharm, Inc.K861490PERMACLEAR SOLUTION CAT. NO. 4950Helena LaboratoriesK855109CLEARENE, CLEARING AGENTSurgipath Medical Industries, Inc.K854083XYLENE SUBSTITUTE MONTANTLerner Laboratories, Inc.K842861PRO-PAR CLEARANTAnatech, Ltd.

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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