Stratus Myoglobin Gluorometric Enzyme Immunoassay
FDA 510(k) K965213 · Dade Intl., Inc.
510(k) numberK965213
Submission
- Device name
- Stratus Myoglobin Gluorometric Enzyme Immunoassay
- Applicant
- Dade Intl., Inc.
Miami, FL, US - Received
- December 30, 1996
- Decision date
- February 10, 1997
- 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
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|---|---|---|---|
| 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 |
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| 510(k) | Device | Decision |
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| K973974 | Dade Tru-Liquid Cardiac ControlJJT · Traditional | 11/06/1997SE |
| K973668 | Cardiac Troponin-I (Trop) CalibratorJIT · Traditional | 10/20/1997SE |
| K972524 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 09/08/1997SE |
| K972782 | Dade Stratus Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 08/15/1997SE |
| K972287 | Dade Tru-Liquid Bilirubin ControlJJX · Traditional | 07/07/1997SE |
| K964660 | Paramax Cholesterol ReagentCHH · Traditional | 06/04/1997SE |
| K970676 | Dried Gram-Negative Mic/Combo PanelsJWY · Traditional | 05/02/1997SE |
| K964715 | Paramax Salicylate ReagentDKJ · Traditional | 04/25/1997SE |
Questions and answers
When was Stratus Myoglobin Gluorometric Enzyme Immunoassay cleared by the FDA?
Stratus Myoglobin Gluorometric Enzyme Immunoassay (K965213) received a 510(k) decision of Substantially Equivalent on February 10, 1997, 42 days after the submission was received.
What is the product code of K965213?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.