Modified Ferritin Enzyme Immunoassay Test Kit
FDA 510(k) K896585 · Medix Biotech, Inc.
510(k) numberK896585
Submission
- Device name
- Modified Ferritin Enzyme Immunoassay Test Kit
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- November 21, 1989
- Decision date
- December 4, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
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| K924259 | Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100JHI · Traditional | 11/25/1992SE |
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| K921700 | TSH Enzyme Immunoassay Test Kit Cat. No. KIF4093JLW · Traditional | 06/29/1992SE |
| K920712 | Medix Biotech Throxine Enzyme Immunoassay Test KitKLI · Traditional | 03/27/1992SE |
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Questions and answers
When was Modified Ferritin Enzyme Immunoassay Test Kit cleared by the FDA?
Modified Ferritin Enzyme Immunoassay Test Kit (K896585) received a 510(k) decision of Substantially Equivalent on December 4, 1989, 13 days after the submission was received.
What is the product code of K896585?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.