Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I
FDA 510(k) K973126 · Biosite Incorporated
510(k) numberK973126
Submission
- Device name
- Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I
- Applicant
- Biosite Incorporated
San Diego, CA, US - Received
- August 20, 1997
- Decision date
- October 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JHX – Fluorometric Method, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
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| K041596 | Architect Stat Ck-Mb ImmunoassayJHX · Traditional | Fisher Diagnostics | 07/21/2004SE |
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| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | Diagnostic Products Corp. | 01/21/2004SE |
| K030012 | Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372JHX · Special | Beckman Coulter, Inc. | 01/17/2003SE |
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Questions and answers
When was Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I cleared by the FDA?
Triage Cardiac Panel, Triage Troponin-I, Triage Ck-Mb, Triage Myoglobin, Triage Troponin-I and Ck-Mb, Triage Troponin-I (K973126) received a 510(k) decision of Substantially Equivalent on October 6, 1997, 47 days after the submission was received.
What is the product code of K973126?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.