STA-LIATEST FREE PROTEIN S TEST KIT— 510(k) K010963
Substantially EquivalentDiagnostica Stago, Inc.
FDA 510(k) clearance K010963 for STA-LIATEST FREE PROTEIN S TEST KIT, Substantially Equivalent on 2001-06-06. Applicant: Diagnostica Stago, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostica Stago, Inc.
- Product code
- Code GGP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parisppany, NJ, US
Recent devices under product code GGP
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view allRecalls naming K010963
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010963.
Data sourced from openFDA. This site is unofficial and independent of the FDA.