Total Hige Enzyme Immunoassay
FDA 510(k) K850786 · Nms Pharmaceuticals, Inc.
510(k) numberK850786
Submission
- Device name
- Total Hige Enzyme Immunoassay
- Applicant
- Nms Pharmaceuticals, Inc.
Newport Beach, CA, US - Received
- February 26, 1985
- Decision date
- April 12, 1985
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K861202 | Tru-Level Control Immunoassay ControlsJJY · Traditional | 01/09/1987SE |
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| K860828 | Foretel, Color Ovulation TestCEP · Traditional | 08/04/1986SE |
| K853925 | Quantitative Determination of HCG in Serum-ElisaJHI · Traditional | 12/02/1985SE |
| K851445 | Color Ovulation TestCEP · Traditional | 07/29/1985SE |
| K850431 | Ez-Detect Visual Color Test for Blood in StoolKHE · Traditional | 06/17/1985SE |
| K850787 | Solid Phase Free Estriol Enzyme ImmunoassayCGI · Traditional | 03/26/1985SE |
| K842499 | NMS 1043 Enzyme Immunoassay KitJHI · Traditional | 09/14/1984SE |
Questions and answers
When was Total Hige Enzyme Immunoassay cleared by the FDA?
Total Hige Enzyme Immunoassay (K850786) received a 510(k) decision of Substantially Equivalent on April 12, 1985, 45 days after the submission was received.
What is the product code of K850786?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.