Ck-Mb(Immunological)
FDA 510(k) K802521 · Biodynamics Corp.
510(k) numberK802521
Submission
- Device name
- Ck-Mb(Immunological)
- Applicant
- Biodynamics Corp.
Walker, MI, US - Received
- October 15, 1980
- Decision date
- November 12, 1980
- 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 |
|---|---|---|
| K051675 | Biodynamics Bia 500 Biompedance Body Composition AnalyzerMNW · Traditional | 03/16/2006SE |
| K884033 | Biodynamics Model 200 Body Composition AnalyzerDSB · Traditional | 11/17/1988SE |
| K881631 | Biodynamics Autotransfusion ReservoirCAC · Traditional | 09/09/1988SE |
| K881968 | Biodynamics Model BI-400 Body Composition AnalyzerDSB · Traditional | 07/28/1988SE |
| K874361 | Biodynamics Model BI-300 Body Composition AnalyzerDSB · Traditional | 03/16/1988SE |
| K873807 | Autotransfusion ApparatusCAC · Traditional | 03/09/1988SE |
| K874034 | ADR-22 Automatic Dialyzer ReprocessorLIF · Traditional | 10/23/1987SE |
| K870052 | Infumix Mixing ContainerKPE · Traditional | 02/27/1987SE |
| K822716 | Universal CentrifugeJPI · Traditional | 09/30/1982SE |
| K822715 | Platelet CentrifugeJQC · Traditional | 09/30/1982SE |
Questions and answers
When was Ck-Mb(Immunological) cleared by the FDA?
Ck-Mb(Immunological) (K802521) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 28 days after the submission was received.
What is the product code of K802521?
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.