BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647
FDA 510(k) K033036 · Beckman Coulter, Inc.
510(k) numberK033036
Submission
- Device name
- BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- September 29, 2003
- Decision date
- February 3, 2004
- 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 |
| K233946 | Immulite® 2000 Br-MaMOI · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 03/13/2024SE |
| 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 |
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| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
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Questions and answers
When was BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647 cleared by the FDA?
BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647 (K033036) received a 510(k) decision of Substantially Equivalent on February 3, 2004, 127 days after the submission was received.
What is the product code of K033036?
The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.