Modified Ferritin Enzyme Imunoassay Test Kit
FDA 510(k) K920046 · Medix Biotech, Inc.
510(k) numberK920046
Submission
- Device name
- Modified Ferritin Enzyme Imunoassay Test Kit
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- January 6, 1992
- Decision date
- January 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K952873 | Medix Biotech Strep a Antigen Detection Test (Modification)GTZ · Traditional | 09/08/1995SE |
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| K932482 | Medix Biotech Bestest Strep a Cat. No. BSF1010GTZ · Traditional | 07/18/1994SE |
| K932758 | Medix Biotech Bestest Hcg-Urine Test KitJHI · Traditional | 09/28/1993SE |
| K925436 | Medix Biotech Total T3 Enzyme Immunoassay Test KitCDP · Traditional | 12/28/1992SE |
| K924259 | Medix Biotech Bestest(Tm) Hcg-Urine, Cat# B1H0100JHI · Traditional | 11/25/1992SE |
| K922047 | Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064DGC · Traditional | 08/05/1992SE |
| 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 |
| K920345 | Prolactin Enzyme Immunoassay Test Kit (Modified)CFT · Traditional | 03/18/1992SE |
Questions and answers
When was Modified Ferritin Enzyme Imunoassay Test Kit cleared by the FDA?
Modified Ferritin Enzyme Imunoassay Test Kit (K920046) received a 510(k) decision of Substantially Equivalent on January 28, 1992, 22 days after the submission was received.
What is the product code of K920046?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.