INSTANT-VIEW TCA URINE TEST

FDA 510(k) Premarket Notification · Submission K022693 · Applicant: Alfa Scientific Designs, Inc.

Public Record 510(k) Submission Decision Date: 2002-12-09 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K022693.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K022693

Applicant / Sponsor

Alfa Scientific Designs, Inc.

Device Name

INSTANT-VIEW TCA URINE TEST

Product Code

MLK

Decision Date

2002-12-09

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Abbreviated

Third Party Flag

Date Received

2002-08-13

Related Establishments / Registrations

Alere San Diego, Inc. Registration: 2020952 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
ALFA SCIENTIFIC DESIGNS, INC. Registration: 2060833 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.