STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K965213
Substantially EquivalentDade Intl., Inc.
FDA 510(k) clearance K965213 for STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1997-02-10. Applicant: Dade Intl., Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Intl., Inc.
- Product code
- Code DDR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5680
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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More clearances from Dade Intl., Inc.
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