High Performance Cannabinoid Controls
FDA 510(k) K863117 · Rapid Diagnostic Laboratories, Inc.
510(k) numberK863117
Submission
- Device name
- High Performance Cannabinoid Controls
- Applicant
- Rapid Diagnostic Laboratories, Inc.
Port Washington, NY, US - Received
- August 14, 1986
- Decision date
- September 25, 1986
- 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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More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903909 | Blind Controls for Drugs of Abuse TestingDIF · Traditional | 10/26/1990SE |
| K890030 | New Low Level Drug Mixture ControlDIF · Traditional | 01/23/1989SE |
| K875216 | High Performance CalibratorsDKB · Traditional | 06/22/1988SE |
| K871694 | Hyperformance Controls (Hp-Controls)DIF · Traditional | 07/07/1987SE |
| K850139 | Cobe Cop Filter Cardiopulmonary Prebypass FilterKRJ · Traditional | 04/10/1985SE |
Questions and answers
When was High Performance Cannabinoid Controls cleared by the FDA?
High Performance Cannabinoid Controls (K863117) received a 510(k) decision of Substantially Equivalent on September 25, 1986, 42 days after the submission was received.
What is the product code of K863117?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.