STA- COAG CONTROL (N+ABN) PLUS— 510(k) K120014
Substantially EquivalentDiagnostica Stago, Inc.
FDA 510(k) clearance K120014 for STA- COAG CONTROL (N+ABN) PLUS, Substantially Equivalent on 2013-03-14. Applicant: Diagnostica Stago, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostica Stago, Inc.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parisppany, NJ, US
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