Chromesytems Toxicology Calibrators and Controls
FDA 510(k) K080459 · Chromsystems Instruments & Chemicals GmbH
510(k) numberK080459
Submission
- Device name
- Chromesytems Toxicology Calibrators and Controls
- Applicant
- Chromsystems Instruments & Chemicals GmbH
Marietta, GA, US - Received
- February 20, 2008
- Decision date
- November 17, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K946119 | Roche-Tdm Onlein(Tm) ControlsLAS · Traditional | Roche Diagnostic Systems, Inc. | 02/07/1995SE |
Questions and answers
When was Chromesytems Toxicology Calibrators and Controls cleared by the FDA?
Chromesytems Toxicology Calibrators and Controls (K080459) received a 510(k) decision of Substantially Equivalent on November 17, 2009, 636 days after the submission was received.
What is the product code of K080459?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.