Cardiozyme Plus Ck-Mb, #65045
by Emd Chemicals, Inc. 510(k)
Active
510(k) K821464
Overview
Cardizyme Plus CK-MB, #65045 is a clinical chemistry reagent used to measure creatine kinase‑MB (CK‑MB) isoenzymes by NAD reduction/NADH oxidation methods. The assay detects the specific isoenzyme activity of CK‑MB in serum or plasma samples for cardiac biomarker testing.
The product is classified as a Class II medical device (product code CGS) and received FDA 510(k) clearance (K821464) on 2 June 1982 under regulation 862.1215. It is supplied as a single‑use kit identified by the model number #65045 and is intended for use in clinical laboratory settings. The device is manufactured by Emd Chemicals, Inc. in Mchenry, Illinois, United States.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821464 | Date2 Jun 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CGS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Emd Chemicals, Inc.
Questions
What is the CARDIOZYME PLUS CK-MB #65045 used for?
The CARDIOZYME PLUS CK-MB #65045 is a clinical chemistry reagent used to measure creatine kinase-MB (CK-MB) isoenzymes in serum or plasma samples. It employs NAD reduction/NADH oxidation methods to detect specific CK-MB activity, which serves as a cardiac biomarker for assessing myocardial injury in clinical laboratory settings.
How is the CARDIOZYME PLUS CK-MB #65045 supplied and is it reusable?
The device is supplied as a single-use kit identified by model number #65045. It is intended for one-time use only in clinical laboratory settings and is not designed for reuse, ensuring consistent reagent performance and minimizing contamination risks across tests.
What regulatory pathway was used for the CARDIOZYME PLUS CK-MB #65045?
The CARDIOZYME PLUS CK-MB #65045 received FDA 510(k) clearance (K821464) on June 2, 1982, under regulation 862.1215. It was found substantially equivalent to a predicate device and is classified as a Class II medical device with product code CGS in the Clinical Chemistry specialty.