Spectral's Cardiac Status Ck-Mb Rapid Test
FDA 510(k) K022409 · Spectral Diagnostics, Inc.
510(k) numberK022409
Submission
- Device name
- Spectral's Cardiac Status Ck-Mb Rapid Test
- Applicant
- Spectral Diagnostics, Inc.
Toronto, Ontario, CA - Received
- July 24, 2002
- Decision date
- September 30, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JHT – Chromatographic Separation, Cpk Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991299 | Modification to Cardiac Status Ck-Mb/Myoglobin Rapid One-Step Test, Lifesign Mi…JHT · Traditional | Princeton BioMeditech Corp. | 05/28/1999SE |
| K930359 | Cardio Rep-Cat. No. 1400 & CK Isoforms Kit 3305JHT · Traditional | Helena Laboratories | 04/12/1993SE |
| K904866 | Coulter Ck-Mb Isoenzyme ReagentJHT · Traditional | Coulter Electronics, Inc. | 12/13/1990SE |
| K904721 | DSL Ck-Mb (DSL #3200)JHT · Traditional | Diagnostic Systems Laboratories, Inc. | 12/13/1990SE |
| K901450 | Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 05/15/1990SE |
| K896170 | Rep CK Isoforms Kit Cat. No. 3081, 3082, 3083JHT · Traditional | Helena Laboratories | 02/16/1990SE |
| K881168 | Creatine Kinase (CK) Isoenzyme MBJHT · Traditional | Data Medical Associates, Inc. | 11/10/1988SE |
| K874284 | Shot-Gun Isolat Proced/Measurement Ck-Mb in SerumJHT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 01/21/1988SE |
| K872041 | Coulter Dart Ck-Mb Isoenzyme Reagent SystemJHT · Traditional | Coulter Electronics, Inc. | 09/16/1987SE |
| K872598 | Micromi-Ck(Tm)JHT · Traditional | Intl. Immunoassay Laboratories, Inc. | 08/03/1987SE |
More from Intl. Immunoassay Laboratories, 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 |
| 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 |
| 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 Spectral's Cardiac Status Ck-Mb Rapid Test cleared by the FDA?
Spectral's Cardiac Status Ck-Mb Rapid Test (K022409) received a 510(k) decision of Substantially Equivalent on September 30, 2002, 68 days after the submission was received.
What is the product code of K022409?
The FDA product code is JHT – Chromatographic Separation, Cpk Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.