Stratus Myoglobin Fluorometric Enzyme Immunoassay
FDA 510(k) K922125 · Baxter Diagnostics, Inc.
510(k) numberK922125
Submission
- Device name
- Stratus Myoglobin Fluorometric Enzyme Immunoassay
- Applicant
- Baxter Diagnostics, Inc.
Miami, FL, US - Received
- May 6, 1992
- Decision date
- July 21, 1992
- 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 |
| K080481 | Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsDDR · Traditional | Beckman Coulter, Inc. | 02/20/2009SE |
| 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 |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934458 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 07/18/1995SE |
| K950817 | Dried Gram Positive Mic/Combo Panels/PneumococciJWY · Traditional | 04/25/1995SE |
| K935704 | Dried Gram-Negative Mic//Combo PanelsLTT · Traditional | 04/14/1995SE |
| K950570 | Stratus Progesterone Fluorometric Enzyme ImmunoassayJLS · Traditional | 04/11/1995SE |
| K945235 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | 03/07/1995SE |
| K941030 | Dried Gram-Negative CefpodoximeLTT · Traditional | 02/16/1995SE |
| K940917 | Loracarbef Gram-Nagative PanelsJWY · Traditional | 02/08/1995SE |
| K941459 | Gram Positive Dried Overnight Panels/LomefloxJWY · Traditional | 02/03/1995SE |
| K941317 | Dried Gram Negative/CefmetazoleJWY · Traditional | 01/31/1995SE |
| K942267 | Dried Gram-Positive Mic/Combo Panels/CefmetazoleJWY · Traditional | 01/09/1995SE |
Questions and answers
When was Stratus Myoglobin Fluorometric Enzyme Immunoassay cleared by the FDA?
Stratus Myoglobin Fluorometric Enzyme Immunoassay (K922125) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 76 days after the submission was received.
What is the product code of K922125?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.