Instant-View Tca Urine Test
FDA 510(k) K022693 · Alfa Scientific Designs, Inc.
510(k) numberK022693
Submission
- Device name
- Instant-View Tca Urine Test
- Applicant
- Alfa Scientific Designs, Inc.
Poway, CA, US - Received
- August 13, 2002
- Decision date
- December 9, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLK – Thin Layer Chromatography, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Specialty
- Clinical Toxicology
Other 510(k)s with product code MLK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010734 | Branan Medical Corperation Monitect Tca Drug Screen Test, Model MC21 and MD21MLK · Traditional | Branan Medical Corp. | 07/30/2001SE |
More from Branan Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | 02/23/2018SE |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | 02/15/2018SE |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…DKZ · Traditional | 06/24/2016SE |
| K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)DKZ · Abbreviated | 10/07/2013SE |
| K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…DJG · Abbreviated | 07/06/2010SE |
| K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestKHE · Traditional | 06/21/2007SE |
| K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test(Cassette…DJG · Abbreviated | 05/07/2007SE |
| K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…DJG · Abbreviated | 07/25/2006SE |
| K042227 | Instant-View Troponin I TestMMI · Traditional | 11/19/2004SE |
| K024360 | Instant-View H. Pylori One Step Rapid TestLYR · Traditional | 06/10/2003SE |
Questions and answers
When was Instant-View Tca Urine Test cleared by the FDA?
Instant-View Tca Urine Test (K022693) received a 510(k) decision of Substantially Equivalent on December 9, 2002, 118 days after the submission was received.
What is the product code of K022693?
The FDA product code is MLK – Thin Layer Chromatography, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.