Immulite® 2000 Br-Ma
FDA 510(k) K233946 · Siemens Healthcare Diagnostics Products, Ltd.
510(k) numberK233946
Submission
- Device name
- Immulite® 2000 Br-Ma
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
Llanberis, GB - Received
- December 14, 2023
- Decision date
- March 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOI – System, Test, Immunological, Antigen, Tumor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
Other 510(k)s with product code MOI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240403 | Access BR MonitorMOI · Traditional | Beckman Coulter, Inc. | 05/09/2024SE |
| K192524 | Lumipulse G CA15-3MOI · Traditional | Fujirebio Diagnostics,Inc. | 09/04/2020SE |
| K193489 | ADVIA Centaur BRMOI · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/13/2020SE |
| K192777 | ADVIA Centaur CA 15-3 assayMOI · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/22/2019SE |
| K181492 | Elecsys CA 15-3 IIMOI · Traditional | Roche Diagnostics | 06/22/2018SE |
| K171605 | Elecsys CA 15-3 IIMOI · Traditional | Roche Diagnostics | 02/20/2018SE |
| K100344 | Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…MOI · Traditional | Siemens Healthcare Diagnostics | 04/18/2011SE |
| K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model(S) 387620,AND 387647MOI · Special | Beckman Coulter, Inc. | 10/26/2007SE |
| K042732 | Architect Ca 15-3 AssayMOI · Traditional | Fujirebio Diagnostics,Inc. | 12/22/2004SE |
| K033036 | BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620…MOI · Traditional | Beckman Coulter, Inc. | 02/03/2004SE |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)DHB · Traditional | 09/04/2026SE |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…QLU · Traditional | 10/10/2024SE |
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)CFN · Special | 12/13/2023SE |
| K213510 | Immulite/Immulite 1000 Om-Ma, Immulite 2000 Om-MaLTK · Traditional | 09/08/2023SE |
| K220728 | vWF AgGGP · Traditional | 06/02/2023SE |
| K212559 | CardioPhase® hsCRPNQD · Special | 12/16/2022SE |
| K212379 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | 03/02/2022SE |
| K201496 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | 10/29/2021SE |
| K193047 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | 07/14/2021SE |
| K203270 | IMMULITE/IMMULITE® 1000 CortisolCGR · Traditional | 01/15/2021SE |
Questions and answers
When was Immulite® 2000 Br-Ma cleared by the FDA?
Immulite® 2000 Br-Ma (K233946) received a 510(k) decision of Substantially Equivalent on March 13, 2024, 90 days after the submission was received.
What is the product code of K233946?
The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.