Company ยท US
Aniara Diagnostica LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2009. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
11recalls (4 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | Aniara Diagnostica LLC 5-PLASMA Bivalirudin Control, Model Number 5D-44905 Open, Classified |
GGN | None listed |
| Aug 5, 2026 | Aniara Diagnostica LLC 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 Open, Classified |
JIX | None listed |
| Aug 5, 2026 | Aniara Diagnostica LLC 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 Open, Classified |
JIT | None listed |
| May 12, 2026 | Aniara Diagnostica LLC ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A Open, Classified |
LCO | K071255 |
| Mar 6, 2023 | Aniara Diagnostica LLC BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein Open, Classified |
GGP | K050365 |
| Jun 28, 2022 | Aniara Diagnostica LLC BIOPHEN UFH Control Plasma Terminated |
GGN | K051472 |
| Jul 19, 2019 | Aniara Diagnostica LLC ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. Terminated |
LCO | K071255 |
| Jul 19, 2019 | Aniara Diagnostica LLC ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. Terminated |
LCO | K071255 |
| Mar 19, 2019 | Aniara Diagnostica LLC BIOPHEN LMWH Control C4, REF 224201 Terminated |
GGN | K051472 |
| Mar 19, 2019 | Aniara Diagnostica LLC BIOPHEN UFH Control C1, REF 224101 Terminated |
GGN | K051472 |
| Mar 19, 2019 | Aniara Diagnostica LLC BIOPHEN UFH Control C2, REF 223901 Terminated |
GGN | K051472 |