STA-QUALITY HBPM/LMWH KIT— 510(k) K010324
Substantially EquivalentDiagnostica Stago, Inc.
FDA 510(k) clearance K010324 for STA-QUALITY HBPM/LMWH KIT, Substantially Equivalent on 2001-04-09. 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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More clearances from Diagnostica Stago, Inc.
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