Cannabinoid Urine Controls
FDA 510(k) K932113 · Diagnostic Reagents, Inc.
510(k) numberK932113
Submission
- Device name
- Cannabinoid Urine Controls
- Applicant
- Diagnostic Reagents, Inc.
Mountain View, CA, US - Received
- May 3, 1993
- Decision date
- June 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K983159 | Drugs of Abuse Urine Calibrators and ControlsDKB · Traditional | 11/05/1998SE |
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| K972835 | 50NG/ML Cocaine Metabolite CalibratorDLJ · Traditional | 08/28/1997SE |
| K972526 | Methadone Eia AssayDJR · Traditional | 08/04/1997SE |
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Questions and answers
When was Cannabinoid Urine Controls cleared by the FDA?
Cannabinoid Urine Controls (K932113) received a 510(k) decision of Substantially Equivalent on June 29, 1993, 57 days after the submission was received.
What is the product code of K932113?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.