K-Assay Myoglobin Assay, K-Assay Myoglobin Calibrator
FDA 510(k) K992976 · Kamiya Biomedical Co.
510(k) numberK992976
Submission
- Device name
- K-Assay Myoglobin Assay, K-Assay Myoglobin Calibrator
- Applicant
- Kamiya Biomedical Co.
Seattle, WA, US - Received
- September 3, 1999
- Decision date
- November 1, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K121232 | K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin CalibratorDBF · Traditional | 05/24/2012SE |
| K093137 | K-Assay Cystatin C Reagent, Calibrator and ControlNDY · Traditional | 09/28/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | 04/29/2010SE |
| K050944 | K-Assay Ferritin (2) & Ferritin Calibrator SetDBF · Traditional | 12/23/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | 12/10/2004SE |
| K030687 | K-Assay D-Dimer, K-Assay D-Dimer Calibrator, Models KAI-090; KAJ-091CDAP · Traditional | 06/27/2003SE |
| K023828 | K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP…DCK · Traditional | 02/04/2003SE |
| K023853 | K-Assay Lp(A) ControlsDFC · Traditional | 12/13/2002SE |
Questions and answers
When was K-Assay Myoglobin Assay, K-Assay Myoglobin Calibrator cleared by the FDA?
K-Assay Myoglobin Assay, K-Assay Myoglobin Calibrator (K992976) received a 510(k) decision of Substantially Equivalent on November 1, 1999, 59 days after the submission was received.
What is the product code of K992976?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.