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)

TOXI*LAB LTD OPIATE SYSTEM

K-Number: K932209 · 1993-09-24

ApplicantToxi-Lab, Inc.
Decision Date1993-09-24
Product CodeLAI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOXI*LAB LTD OPIATE SYSTEM 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 1993-09-24 under 510(k) number K932209. The device is classified under product code LAI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXI*LAB LTD OPIATE SYSTEM?

TOXI*LAB LTD OPIATE SYSTEM is a medical device that received FDA 510(k) clearance on 1993-09-24. The listed applicant is Toxi-Lab, Inc.. The 510(k) number is K932209.

When did TOXI*LAB LTD OPIATE SYSTEM receive FDA 510(k) clearance?

TOXI*LAB LTD OPIATE SYSTEM received FDA 510(k) clearance on 1993-09-24, under 510(k) number K932209.

Who is the listed applicant for TOXI*LAB LTD OPIATE SYSTEM?

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 TOXI*LAB LTD OPIATE SYSTEM?

The FDA product code for TOXI*LAB LTD OPIATE SYSTEM is LAI.

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.

K923337ON*SITE ALCOHOLK903223ON-SITE ALCOHOLK901694SPEC(TM) EXTRACTION CARTRIDGEK900626ALPHA URINE SAMPLE

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.

↑