Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin Calibrators
FDA 510(k) K080481 · Beckman Coulter, Inc.
510(k) numberK080481
Submission
- Device name
- Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin Calibrators
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- February 22, 2008
- Decision date
- February 20, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDR – Myoglobin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5680
- Specialty
- Immunology
Other 510(k)s with product code DDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231832 | Access MyoglobinDDR · Traditional | Beckman Coulter, Inc. | 09/18/2023SE |
| K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control SetDDR · Traditional | Diazyme Laboratories | 06/07/2013SE |
| K122599 | Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorDDR · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/03/2012SE |
| K083260 | Elecsys Myoglobin Stat, and Elecsys MyoglobinDDR · Traditional | Roche Diagnostics | 10/16/2009SE |
| K061683 | Tina-Quant Myoglobin GEN.2 Test SystemDDR · Traditional | Roche Diagnostics Corp. | 07/21/2006SE |
| K042924 | Architect Stat Myo ImmunoassayDDR · Traditional | Fisher Diagnostics | 01/24/2005SE |
| K042982 | Quantex MyoglobinDDR · Traditional | Instrumentation Laboratory CO | 12/22/2004SE |
| K033300 | Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersDDR · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/05/2003SE |
| K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…DDR · Traditional | Beckman Coulter, Inc. | 06/28/2002SE |
| K012040 | Ramp Myoglobin AssayDDR · Traditional | Response Biomedical Corp. | 12/18/2001SE |
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Questions and answers
When was Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin Calibrators cleared by the FDA?
Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin Calibrators (K080481) received a 510(k) decision of Substantially Equivalent on February 20, 2009, 364 days after the submission was received.
What is the product code of K080481?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.