Biostix (Tm)Hcg--Simple Pregnancy Test
FDA 510(k) K892654 · Princeton Biomedix
510(k) numberK892654
Submission
- Device name
- Biostix (Tm)Hcg--Simple Pregnancy Test
- Applicant
- Princeton Biomedix
Somerset, NJ, US - Received
- April 13, 1989
- Decision date
- June 19, 1989
- 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
Other 510(k)s with product code DHA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | Ortho Clinical Diagnostics | 05/08/2024SE |
| 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 |
|---|---|---|
| K942052 | Lifesign Mi MyoglobinDDR · Traditional | 02/07/1995SE |
| K925355 | Biosign(Tm_ Rubella - Rubella Antibody TestLFX · Traditional | 07/12/1994SE |
| K930185 | Ovusign Lh/Conception Plus/Ovudate LH One-StepCEP · Traditional | 03/04/1993SE |
| K925183 | Biosign(Tm) Mono-Infect Mono Hetero Antibody TestKTN · Traditional | 02/23/1993SE |
| K926308 | Lifesign HCG - One Step Home Pregnancy TestLCX · Traditional | 01/26/1993SE |
| K901011 | Biosign Hcg-One Step Pregnancy TestJHI · Traditional | 05/04/1990SE |
| K894750 | Biostix I. HCG - One Step Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K894705 | Biospot Hcg-Rapid Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K761315 | Alkaline Phosphatase (Alp)/PnppCJE · Traditional | 02/24/1977SE |
| K760346 | Assay for Gamma GlutamyltransferaseJPZ · Traditional | 10/27/1976SE |
Questions and answers
When was Biostix (Tm)Hcg--Simple Pregnancy Test cleared by the FDA?
Biostix (Tm)Hcg--Simple Pregnancy Test (K892654) received a 510(k) decision of Substantially Equivalent on June 19, 1989, 67 days after the submission was received.
What is the product code of K892654?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.