Reference Material for DELTA-9-THC-COOH in Human Urine
FDA 510(k) K992151 · Consolidated Technologies, Inc.
510(k) numberK992151
Submission
- Device name
- Reference Material for DELTA-9-THC-COOH in Human Urine
- Applicant
- Consolidated Technologies, Inc.
Austin, TX, US - Received
- June 24, 1999
- Decision date
- July 14, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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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 |
| 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 |
More from Roche Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000116 | Qualitrol Urinalysis with Microscopics Control, Levels 1,2 and 3JJY · Traditional | 02/15/2000SE |
| K992578 | Urine Chemistry Control, Level 2JJW · Traditional | 09/03/1999SE |
| K992576 | Urine Chemistry Control, Level 1JJW · Traditional | 09/03/1999SE |
| K981339 | Quickcheck Lyophilized Chemistry Control Conformance Chemistry Control C3JJY · Traditional | 04/21/1998SE |
| K974699 | Reference Material for Amphetamine/Methamphetamine in Human UrineDKB · Traditional | 01/22/1998SE |
| K973469 | Quikcheck Unassayed Chemistry Control Levels 1 and 2, Conformancemccliquichem Unassayed…JJY · Traditional | 09/25/1997SE |
| K972146 | Qualitrol Unassayed H. Pylori Control Set Positive and Negative ControlsLYR · Traditional | 07/08/1997SE |
| K972080 | Qualitrol DHP Immunoassay Control Levels 1,2 and 3, Conformancee Mcc-Ligand Control…JJY · Traditional | 06/18/1997SE |
| K961815 | Qualitrol Ana Control Serum SetLKJ · Traditional | 09/27/1996SE |
| K961550 | Qualitrol Mono Control Serum SetKTN · Traditional | 09/24/1996SE |
Questions and answers
When was Reference Material for DELTA-9-THC-COOH in Human Urine cleared by the FDA?
Reference Material for DELTA-9-THC-COOH in Human Urine (K992151) received a 510(k) decision of Substantially Equivalent on July 14, 1999, 20 days after the submission was received.
What is the product code of K992151?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.