HCG Enzyme Immunoassay Test Kit Catalog #MB-1013
FDA 510(k) K873872 · Medix Biotech, Inc.
510(k) numberK873872
Submission
- Device name
- HCG Enzyme Immunoassay Test Kit Catalog #MB-1013
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- September 22, 1987
- Decision date
- October 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHA – System, Test, Human Chorionic Gonadotropin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
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| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)DHA · Traditional | Shenzhen Yhlo Biotech Co., Ltd. | 12/11/2023SE |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems TrackDHA · Traditional | Abbott Laboratories | 06/05/2023SE |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample…DHA · Traditional | Abbott Laboratories | 05/19/2023SE |
| K221990 | Access Total ßhCG (5th IS)DHA · Traditional | Beckman Coulter, Inc. | 12/27/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | Diazyme Laboratories, Inc. | 12/13/2021SE |
| K203227 | Elecsys HCG STATDHA · Traditional | Roche Diagnostics | 08/18/2021SE |
| K200210 | ADVIA Centaur® Total hCG assayDHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2021SE |
| K192547 | MAGLUMI 2000 HCG/ß-HCGDHA · Traditional | Shenzhen New Industries Biomedical Engineering… | 01/17/2020SE |
| K192790 | Atellica IM Total hCG (ThCG)DHA · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/30/2019SE |
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| 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 HCG Enzyme Immunoassay Test Kit Catalog #MB-1013 cleared by the FDA?
HCG Enzyme Immunoassay Test Kit Catalog #MB-1013 (K873872) received a 510(k) decision of Substantially Equivalent on October 28, 1987, 36 days after the submission was received.
What is the product code of K873872?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.