Cannabinoid Urine Controls
FDA 510(k) K921141 · Diagnostic Reagents, Inc.
510(k) numberK921141
Submission
- Device name
- Cannabinoid Urine Controls
- Applicant
- Diagnostic Reagents, Inc.
Mountain View, CA, US - Received
- March 10, 1992
- Decision date
- April 17, 1992
- 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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| K062942 | Quantimetrix Nicosure Cotinine Urine ControlLAS · Traditional | Quantimetrix Corp. | 10/30/2006SE |
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| 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 |
|---|---|---|
| K983268 | Modification of Tricyclic Serum Tox Eia AssayLFH · Traditional | 11/18/1998SE |
| K983812 | Napa Eia AssayLAN · Traditional | 11/16/1998SE |
| K983323 | Digoxin ImmunoassayKXT · Traditional | 11/12/1998SE |
| K983280 | Vancomycin Eia AssayLEH · Traditional | 11/06/1998SE |
| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
| K973102 | Lidocaine Eia AssayKLR · Traditional | 09/12/1997SE |
| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
| K964212 | Quinidine Enzyme ImmunoassayLBZ · Traditional | 12/18/1996SE |
| K963835 | Digoxin Enzyme ImmunoassayKXT · Traditional | 12/10/1996SE |
Questions and answers
When was Cannabinoid Urine Controls cleared by the FDA?
Cannabinoid Urine Controls (K921141) received a 510(k) decision of Substantially Equivalent on April 17, 1992, 38 days after the submission was received.
What is the product code of K921141?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.