Toxicology Control
FDA 510(k) K810201 · Utak Laboratories, Inc.
510(k) numberK810201
Submission
- Device name
- Toxicology Control
- Applicant
- Utak Laboratories, Inc.
Mchenry, IL, US - Received
- January 23, 1981
- Decision date
- February 4, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K080459 | Chromesytems Toxicology Calibrators and ControlsLAS · Abbreviated | Chromsystems Instruments & Chemicals GmbH | 11/17/2009SE |
| K072257 | Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-LEVELLAS · Traditional | More Diagnostics | 01/30/2008SE |
| K062942 | Quantimetrix Nicosure Cotinine Urine ControlLAS · Traditional | Quantimetrix Corp. | 10/30/2006SE |
| K051074 | Mas Immunosuppressant ControlsLAS · Traditional | Microgenics Corp. | 06/06/2005SE |
| K040411 | Dri Oxycodone AssayLAS · Traditional | Microgenics Corp. | 05/27/2004SE |
| K032842 | Microgenics Cyclosporine Control KitLAS · Traditional | Microgenics Corp. | 10/17/2003SE |
| K030616 | Cedia Cyclosporine Plus High Range Controls 4 and 5LAS · Traditional | Microgenics Corp. | 03/31/2003SE |
| K992151 | Reference Material for DELTA-9-THC-COOH in Human UrineLAS · Traditional | Consolidated Technologies, Inc. | 07/14/1999SE |
| K970517 | Innofluor Topiramate Control SetLAS · Traditional | Oxis Intl., Inc. | 05/12/1997SE |
| K971210 | Synchron Systems 10 Ng/Ml & 40 Ng/Ml THC Urine ControlsLAS · Traditional | Beckman Instruments, Inc. | 04/17/1997SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903061 | Utak Laboratories Toxicology ControlLAS · Traditional | 04/12/1991SE |
| K883147 | Trace Elements Serum Toxicology ControlJJY · Traditional | 10/06/1988SE |
| K862419 | Serum Vancomycin Toxicology ControlLAS · Traditional | 11/13/1986SE |
| K862418 | Benzodiazepines Toxicology ControlLAS · Traditional | 11/13/1986SE |
| K862421 | Serum Clonazepam Toxicology ControlLAS · Traditional | 11/05/1986SE |
| K862420 | Utak-Stabbs Toxicology ControlJJY · Traditional | 08/04/1986SE |
| K831736 | Tricyclic AntidepressantsDIF · Traditional | 07/28/1983SE |
| K831741 | Flurazepam Toxicology ControlDIF · Traditional | 07/26/1983SE |
| K831738 | Caffine Toxicology ControlLAS · Traditional | 07/26/1983SE |
| K831735 | MaprotilineLAS · Traditional | 07/26/1983SE |
Questions and answers
When was Toxicology Control cleared by the FDA?
Toxicology Control (K810201) received a 510(k) decision of Substantially Equivalent on February 4, 1981, 12 days after the submission was received.
What is the product code of K810201?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.