Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay Controls
FDA 510(k) K961792 · Biocircuits Corp.
510(k) numberK961792
Submission
- Device name
- Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay Controls
- Applicant
- Biocircuits Corp.
Sunnyvale, CA, US - Received
- May 9, 1996
- Decision date
- August 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
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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 |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981634 | Biocircuits Ios Prostate Specific Antigen (Psa) Test Cartridges, Biocircuits Ios Psa…LTJ · Traditional | 10/13/1998SE |
| K980819 | Biocircuits Ios Free Thyroxine (FT4) Test Cartridges Biocircuits Ios ControlsCEC · Traditional | 04/03/1998SE |
| K963770 | Biocircuits Ios Quantitative HCG Test Cartridges/Biocircuits Ios Immunoassay ControlsJJY · Traditional | 12/05/1996SE |
| K961566 | Biocircuits Ios TSH Test Cartridges/Thyroid ControlsJLW · Traditional | 11/18/1996SE |
| K952719 | Biocircuits Ios (In-Office System)KHO · Traditional | 11/22/1995SE |
| K953837 | Biocircuits Ios T4 Test CartridgeKLI · Traditional | 11/20/1995SE |
| K952751 | Biocircuits Ios T4/TU Test CartridgesKLI · Traditional | 11/20/1995SE |
Questions and answers
When was Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay Controls cleared by the FDA?
Biocircuits Ios Serum Pregnancy Test Cartridges/Immunoassay Controls (K961792) received a 510(k) decision of Substantially Equivalent on August 21, 1996, 104 days after the submission was received.
What is the product code of K961792?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.