STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK— 510(k) K984065
Substantially EquivalentDade Behring, Inc.
FDA 510(k) clearance K984065 for STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK, Substantially Equivalent on 1998-12-14. Applicant: Dade Behring, Inc.. Device class: 2.
Clearance details
- Applicant
- Dade Behring, 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
- Newark, DE, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.