SPECTROLYSE PAI-1, MODEL 101201— 510(k) K063323
Substantially EquivalentAmerican Diagnostica, Inc.
FDA 510(k) clearance K063323 for SPECTROLYSE PAI-1, MODEL 101201, Substantially Equivalent on 2007-08-15. Applicant: American Diagnostica, Inc.. Device class: 2.
Clearance details
- Applicant
- American Diagnostica, 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
- Stamford, CT, US
Recent devices under product code GGP
view allMore clearances from American Diagnostica, Inc.
view allRecalls naming K063323
K-number listed on FDA's recall record- Z-0463-2013 — Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.
- Z-2431-2012 — Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063323.
Data sourced from openFDA. This site is unofficial and independent of the FDA.