CARDIOZYME PLUS CK-MB, #65045— 510(k) K821464
Substantially EquivalentEmd Chemicals, Inc.
FDA 510(k) clearance K821464 for CARDIOZYME PLUS CK-MB, #65045, Substantially Equivalent on 1982-06-02. Applicant: Emd Chemicals, Inc.. Device class: 2.
Clearance details
- Applicant
- Emd Chemicals, Inc.
- Product code
- Code CGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CGS
view allMore clearances from Emd Chemicals, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.