Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care CKMB Testpak.
FDA 510(k) K051650 · Dade Behring, Inc.
510(k) numberK051650
Submission
- Device name
- Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care CKMB Testpak.
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- June 21, 2005
- Decision date
- September 8, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K030012 | Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372JHX · Special | Beckman Coulter, Inc. | 01/17/2003SE |
| K022118 | Immulite Turbo Ck-Mb, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)JHX · Special | Diagnostic Products Corp. | 07/22/2002SE |
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Questions and answers
When was Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care CKMB Testpak. cleared by the FDA?
Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care CKMB Testpak. (K051650) received a 510(k) decision of Substantially Equivalent on September 8, 2005, 79 days after the submission was received.
What is the product code of K051650?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.