Creatine Kinase
FDA 510(k) K160570 · Roche Diagnostics Operations (Rdo)
510(k) numberK160570
Submission
- Device name
- Creatine Kinase
- Applicant
- Roche Diagnostics Operations (Rdo)
Indianapolis, MD, US - Received
- February 29, 2016
- Decision date
- May 25, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHS – Differential Rate Kinetic Method, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102706 | CKMB Udr AssayJHS · Traditional | SENTINEL CH. SpA | 08/19/2011SE |
| K082226 | S40 Creatine Kinase (CK)JHS · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 09/18/2008SE |
| K062128 | The Dimension Vista Flex Reagent Cartridges / Kit AssaysJHS · Special | Dade Behring, Inc. | 08/21/2006SE |
| K990439 | Careside CKJHS · Traditional | Careside, Inc. | 04/19/1999SE |
| K990434 | Careside CKMBJHS · Traditional | Careside, Inc. | 04/19/1999SE |
| K981495 | Immulite Ck-Mb, Catalog # LKCP1 (100 Tests), LKCP5 (500 Tests)JHS · Traditional | Diagnostic Products Corp. | 06/10/1998SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | Ciba Corning Diagnostics Corp. | 06/21/1996SE |
| K952250 | Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High…JHS · Traditional | Dade Intl., Inc. | 07/17/1995SE |
| K945083 | Access Ck-Mb ReagentsJHS · Traditional | Bio-Rad Laboratories, Inc. | 11/21/1994SE |
| K943024 | Kinase IsoenzymeJHS · Traditional | Dupont Medical Products | 08/02/1994SE |
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Questions and answers
When was Creatine Kinase cleared by the FDA?
Creatine Kinase (K160570) received a 510(k) decision of Substantially Equivalent on May 25, 2016, 86 days after the submission was received.
What is the product code of K160570?
The FDA product code is JHS – Differential Rate Kinetic Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.