Multiquant (R) Quantitative Myoglobin Test
FDA 510(k) K982679 · Spectral Diagnostics, Inc.
510(k) numberK982679
Submission
- Device name
- Multiquant (R) Quantitative Myoglobin Test
- Applicant
- Spectral Diagnostics, Inc.
Toronto, Ontario, CA - Received
- July 31, 1998
- Decision date
- October 7, 1998
- 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 |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K052519 | Spectral West Nile Virus Igm Status TestNOP · Traditional | 11/30/2006SE |
| K030057 | Spectral Cardiac Status Ck-Mb/Myoglobin/Troponin I 3-IN-1 TestMMI · Traditional | 03/19/2003SE |
| K022409 | Spectral's Cardiac Status Ck-Mb Rapid TestJHT · Traditional | 09/30/2002SE |
| K020950 | Spectral's 2 in 1 (Tni-Myo)MMI · Traditional | 05/24/2002SE |
| K014105 | Spectral's Troponin IMMI · Traditional | 02/01/2002SE |
| K992127 | Cardioquant Troponin I TestMMI · Traditional | 10/04/1999SE |
| K991447 | Cardioquant Cardiac Assessment ControlsJJY · Traditional | 06/11/1999SE |
| K981474 | Cardiac Status Controls (Ck-Mb/Myoglobin/Troponin I)JJY · Traditional | 05/07/1998SE |
| K972687 | Cardiac Status Controls/Troponin IJJX · Traditional | 07/28/1997SE |
| K972408 | Cardiac Status ControlsJJT · Traditional | 07/25/1997SE |
Questions and answers
When was Multiquant (R) Quantitative Myoglobin Test cleared by the FDA?
Multiquant (R) Quantitative Myoglobin Test (K982679) received a 510(k) decision of Substantially Equivalent on October 7, 1998, 68 days after the submission was received.
What is the product code of K982679?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.