Il Test(Tm) Cocaine
FDA 510(k) K913737 · Instrumentation Laboratory CO
510(k) numberK913737
Submission
- Device name
- Il Test(Tm) Cocaine
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- August 20, 1991
- Decision date
- December 3, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JXO – Enzyme Immunoassay, Cocaine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairJXO · Traditional | Psychemedics Corporation | 06/25/2021SE |
| K111925 | Psychemedics Cocaine EiaJXO · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K923314 | Automates Coma Plus Cocaine Metabolite AssayJXO · Traditional | Serex, Inc. | 08/24/1992SE |
| K921140 | STC Diagnostics AUTO0LYTE Cocaine Metabolite EiaJXO · Traditional | Solarcare Technologies Corp,Inc. | 08/20/1992SE |
| K915785 | STC Diagnostics Benzoylecgonine EiaJXO · Traditional | Solarcare Technologies Corp,Inc. | 03/11/1992SE |
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Questions and answers
When was Il Test(Tm) Cocaine cleared by the FDA?
Il Test(Tm) Cocaine (K913737) received a 510(k) decision of Substantially Equivalent on December 3, 1991, 105 days after the submission was received.
What is the product code of K913737?
The FDA product code is JXO – Enzyme Immunoassay, Cocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3250.