Trace Elements Serum Toxicology Control
FDA 510(k) K883147 · Utak Laboratories, Inc.
510(k) numberK883147
Submission
- Device name
- Trace Elements Serum Toxicology Control
- Applicant
- Utak Laboratories, Inc.
Canyon Country, CA, US - Received
- July 26, 1988
- Decision date
- October 6, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K903061 | Utak Laboratories Toxicology ControlLAS · Traditional | 04/12/1991SE |
| K862419 | Serum Vancomycin Toxicology ControlLAS · Traditional | 11/13/1986SE |
| K862418 | Benzodiazepines Toxicology ControlLAS · Traditional | 11/13/1986SE |
| K862421 | Serum Clonazepam Toxicology ControlLAS · Traditional | 11/05/1986SE |
| K862420 | Utak-Stabbs Toxicology ControlJJY · Traditional | 08/04/1986SE |
| K831736 | Tricyclic AntidepressantsDIF · Traditional | 07/28/1983SE |
| K831741 | Flurazepam Toxicology ControlDIF · Traditional | 07/26/1983SE |
| K831738 | Caffine Toxicology ControlLAS · Traditional | 07/26/1983SE |
| K831735 | MaprotilineLAS · Traditional | 07/26/1983SE |
| K831734 | Amoxapine 8-HYDRO-XYAMOXAPINEDIF · Traditional | 07/26/1983SE |
Questions and answers
When was Trace Elements Serum Toxicology Control cleared by the FDA?
Trace Elements Serum Toxicology Control (K883147) received a 510(k) decision of Substantially Equivalent on October 6, 1988, 72 days after the submission was received.
What is the product code of K883147?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.