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FDA 510(k)

ON.SITE ALCOHOL

K-Number: K963197 · 1996-09-19

ApplicantAnsys, Inc.
Decision Date1996-09-19
Product CodeDML
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ON.SITE ALCOHOL is the device name listed in this FDA 510(k) record. The listed applicant is Ansys, Inc.. It received FDA 510(k) clearance on 1996-09-19 under 510(k) number K963197. The device is classified under product code DML. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ON.SITE ALCOHOL?

ON.SITE ALCOHOL is a medical device that received FDA 510(k) clearance on 1996-09-19. The listed applicant is Ansys, Inc.. The 510(k) number is K963197.

When did ON.SITE ALCOHOL receive FDA 510(k) clearance?

ON.SITE ALCOHOL received FDA 510(k) clearance on 1996-09-19, under 510(k) number K963197.

Who is the listed applicant for ON.SITE ALCOHOL?

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

What is the FDA product code for ON.SITE ALCOHOL?

The FDA product code for ON.SITE ALCOHOL is DML.

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Related Devices (Code: DML)

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.

K013538ETHANOLAbbott LaboratoriesK993980SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409ULSyva Co.K953765AXSYM REA ETHANOLAbbott LaboratoriesK952839BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAYBoehringer Mannheim Corp.K923337ON*SITE ALCOHOLToxi-Lab, Inc.K914777SIGMA PROCEDURE NO. 333-UVSigma Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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