STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K900806
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K900806 for STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1990-03-23. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code JHS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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