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FDA 510(k)

XYLENE

K-Number: K881282 · 1988-04-05

ApplicantAnatech, Ltd.
Decision Date1988-04-05
Product CodeKEM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

XYLENE is the device name listed in this FDA 510(k) record. The listed applicant is Anatech, Ltd.. It received FDA 510(k) clearance on 1988-04-05 under 510(k) number K881282. 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?

XYLENE is a medical device that received FDA 510(k) clearance on 1988-04-05. The listed applicant is Anatech, Ltd.. The 510(k) number is K881282.

When did XYLENE receive FDA 510(k) clearance?

XYLENE received FDA 510(k) clearance on 1988-04-05, under 510(k) number K881282.

Who is the listed applicant for XYLENE?

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

What is the FDA product code for XYLENE?

The FDA product code for XYLENE 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 Anatech, 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.

K882874ZINC FORMALINK882873FIELDTEX HEMATOXYLINK882268ZINC FORMALIN CONCENTRATEK872663DRY-FORMK872498HARRIS HEMATOXYLINK872499ANATECH HEMATOXYLIN-NORMAL STRENGTH

View all 14 devices →

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.

K874461HEMO-SOLChem Pharm, Inc.K861490PERMACLEAR SOLUTION CAT. NO. 4950Helena LaboratoriesK855109CLEARENE, CLEARING AGENTSurgipath Medical Industries, Inc.K854083XYLENE SUBSTITUTE MONTANTLerner Laboratories, Inc.K853694XYLENE SUBSTITUTELerner 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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