Ubi Magiwel(Tm) Ige Quantitative and Qualitative
FDA 510(k) K864142 · United Biotech, Inc.
510(k) numberK864142
Submission
- Device name
- Ubi Magiwel(Tm) Ige Quantitative and Qualitative
- Applicant
- United Biotech, Inc.
Mountain View, CA, US - Received
- October 22, 1986
- Decision date
- December 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| K973692 | Ubi Magiwel C-Reactive Protein(Crp) QuantitativeDCK · Traditional | 02/09/1998SE |
| K973156 | Ubi Magiwel Cocaine MetabolitesDJG · Traditional | 10/28/1997SE |
| K973155 | Ubi Magiwel Opiate MetabolitesDJG · Traditional | 10/28/1997SE |
| K973153 | Ubi Magiwel Amphetamine MetabolitesDJG · Traditional | 10/28/1997SE |
| K962211 | Ubi Magiwel Thyroxine (T4) QuantitativeKLI · Traditional | 07/08/1996SE |
| K961236 | Ubi Magiwel TRIIODOTHYRONINE(T3) QuantitativeCDP · Traditional | 05/30/1996SE |
| K951993 | Ubi Magiwel Ferritin QuantitativeDBF · Traditional | 07/05/1995SE |
| K924689 | Ubi Magiwel(Tm) Helicobacter Pylori IggLYR · Traditional | 08/10/1993SE |
Questions and answers
When was Ubi Magiwel(Tm) Ige Quantitative and Qualitative cleared by the FDA?
Ubi Magiwel(Tm) Ige Quantitative and Qualitative (K864142) received a 510(k) decision of Substantially Equivalent on December 3, 1986, 42 days after the submission was received.
What is the product code of K864142?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.