Cardiac Status Controls (Ck-Mb/Myoglobin/Troponin I)
FDA 510(k) K981474 · Spectral Diagnostics, Inc.
510(k) numberK981474
Submission
- Device name
- Cardiac Status Controls (Ck-Mb/Myoglobin/Troponin I)
- Applicant
- Spectral Diagnostics, Inc.
Toronto, Ontario, CA - Received
- April 24, 1998
- Decision date
- May 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 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 |
| K982679 | Multiquant (R) Quantitative Myoglobin TestDDR · Traditional | 10/07/1998SE |
| K972687 | Cardiac Status Controls/Troponin IJJX · Traditional | 07/28/1997SE |
| K972408 | Cardiac Status ControlsJJT · Traditional | 07/25/1997SE |
Questions and answers
When was Cardiac Status Controls (Ck-Mb/Myoglobin/Troponin I) cleared by the FDA?
Cardiac Status Controls (Ck-Mb/Myoglobin/Troponin I) (K981474) received a 510(k) decision of Substantially Equivalent on May 7, 1998, 13 days after the submission was received.
What is the product code of K981474?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.