Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ON*SITE ALCOHOL

K-Number: K923337 · 1993-01-12

ApplicantToxi-Lab, Inc.
Decision Date1993-01-12
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 Toxi-Lab, Inc.. It received FDA 510(k) clearance on 1993-01-12 under 510(k) number K923337. 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 1993-01-12. The listed applicant is Toxi-Lab, Inc.. The 510(k) number is K923337.

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

ON*SITE ALCOHOL received FDA 510(k) clearance on 1993-01-12, under 510(k) number K923337.

Who is the listed applicant for ON*SITE ALCOHOL?

The FDA 510(k) record lists Toxi-Lab, 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.

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 Toxi-Lab, 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.

K932209TOXI*LAB LTD OPIATE SYSTEMK903223ON-SITE ALCOHOLK901694SPEC(TM) EXTRACTION CARTRIDGEK900626ALPHA URINE SAMPLE

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.K963197ON.SITE ALCOHOLAnsys, Inc.K953765AXSYM REA ETHANOLAbbott LaboratoriesK952839BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAYBoehringer Mannheim Corp.K914777SIGMA PROCEDURE NO. 333-UVSigma Diagnostics, 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.

↑