Profile -Er
FDA 510(k) K033334 · Medtox Diagnostics, Inc.
510(k) numberK033334
Submission
- Device name
- Profile -Er
- Applicant
- Medtox Diagnostics, Inc.
Burlington, NC, US - Received
- October 16, 2003
- Decision date
- November 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS · Traditional | Immunalysis Corporation | 10/14/2016SE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | Assure Tech. Co., Ltd. | 06/04/2015SE |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…DIS · Traditional | Healgen Scientific,, LLC | 04/24/2015SE |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- MethadoneDIS · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/13/2015SE |
| K140665 | GenPrime Snap-Top Split Key CupDIS · Traditional | Genprime, Inc. | 12/08/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | Co-Innovation Biotech Co., Ltd. | 06/16/2014SE |
| K092268 | Randox Bariturates AssayDIS · Traditional | Randox Laboratories, Ltd. | 05/25/2011SE |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | Ucp Biosciences, Inc. | 04/20/2011SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
More from Phamatech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | 01/29/2026SE |
| K100951 | Medtox Buprenorphine TestDJG · Traditional | 10/18/2010SE |
| K100023 | Profile-V Medtoxscan Drugs of Abuse Test System and 12 Drugs Test SystemDJG · Traditional | 04/05/2010SE |
| K091454 | Profile-V Medtoxscan Drugs of Abuse Test SystemDJG · Traditional | 07/24/2009SE |
| K080635 | MedtoxscanDKZ · Traditional | 02/13/2009SE |
| K060351 | Medtox OxycodoneDJG · Traditional | 05/12/2006SE |
| K050394 | Sure-Screen Amphetamine, Benzodiazepine, Cocaine, Methamphetamine/Mdma, Methadone…DKZ · Traditional | 10/25/2005SE |
| K031032 | Verdict II, Profile IIDJG · Special | 07/14/2003SE |
| K022141 | Verdict-IiDJC · Special | 07/30/2002SE |
| K020787 | Verdict-Ii PropoxypheneJXN · Traditional | 05/02/2002SE |
Questions and answers
When was Profile -Er cleared by the FDA?
Profile -Er (K033334) received a 510(k) decision of Substantially Equivalent on November 10, 2003, 25 days after the submission was received.
What is the product code of K033334?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.