DRX Qt. HCG
FDA 510(k) K991532 · Metrika, Inc.
510(k) numberK991532
Submission
- Device name
- DRX Qt. HCG
- Applicant
- Metrika, Inc.
Sunnyvale, CA, US - Received
- May 3, 1999
- Decision date
- September 17, 1999
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K051321 | InviewLCP · Special | 06/13/2005SE |
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| K022661 | A1CNOW for Home UseLCP · Traditional | 12/13/2002SE |
| K020235 | A1CNOW for Professional UseLCP · Special | 02/15/2002SE |
| K020234 | A1CNOW for RX Home UseLCP · Special | 02/15/2002SE |
| K000885 | DRX HBA1C - for Prescription Home UseLCP · Traditional | 09/26/2000SE |
| K000887 | DRX HBA1CLCP · Traditional | 07/26/2000SE |
| K992997 | Osteomark NTX PocJMM · Traditional | 11/09/1999SE |
| K984530 | DRX NTX or, Osteomark NTX Direct ResponseJFY · Traditional | 08/10/1999SE |
| K991917 | Osteomark NTX Point of Care (Poc) Control SetJJW · Traditional | 07/12/1999SE |
Questions and answers
When was DRX Qt. HCG cleared by the FDA?
DRX Qt. HCG (K991532) received a 510(k) decision of Substantially Equivalent on September 17, 1999, 137 days after the submission was received.
What is the product code of K991532?
The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.