Creatine Phosphokinase (CPK)
FDA 510(k) K780504 · Gamma Enterprises, Inc.
510(k) numberK780504
Submission
- Device name
- Creatine Phosphokinase (CPK)
- Applicant
- Gamma Enterprises, Inc.
Mchenry, IL, US - Received
- March 30, 1978
- Decision date
- May 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K160570 | Creatine KinaseJHS · Traditional | Roche Diagnostics Operations (Rdo) | 05/25/2016SE |
| 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 |
More from Bio-Rad Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K790578 | Gamma Smac ReagentsCIG · Traditional | 05/15/1979SE |
| K780507 | Serum Glutamic-Pyruvic TransaminaseCKC · Traditional | 05/03/1978SE |
| K780506 | Carbon Dioxide ReagentsKMS · Traditional | 05/03/1978SE |
| K780505 | Serum Glutamic-Oxaloacetic-TransaminaseCIT · Traditional | 05/03/1978SE |
| K771843 | Wetting Agents · Traditional | 11/22/1977SE |
| K771836 | Lactate DehydrogenaseCFJ · Traditional | 11/22/1977SE |
| K771832 | ChlorideJFS · Traditional | 11/22/1977SE |
| K771838 | Serum IronJIY · Traditional | 11/03/1977SE |
| K771834 | CreatinineCGX · Traditional | 11/03/1977SE |
| K771839 | SodiumJGS · Traditional | 11/02/1977SE |
Questions and answers
When was Creatine Phosphokinase (CPK) cleared by the FDA?
Creatine Phosphokinase (CPK) (K780504) received a 510(k) decision of Substantially Equivalent on May 3, 1978, 34 days after the submission was received.
What is the product code of K780504?
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.