Company ยท US
Aesku, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2006. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 |
| MID | System, Test, Anticardiolipin Immunological | 1 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 1 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 1 |
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 13, 2006 | K062217 | AESKULSKA BETA2-GLYCO-A Aesku, Inc. | MSV |
| Nov 14, 2005 | K051492 | AESKULISA ASCA A Aesku, Inc. | NBT |
| Jun 1, 2005 | K042644 | AESKULISA TTG A AND AESKULISA TTG G Aesku, Inc. | MVM |
| Jun 23, 2004 | K040953 | AESKULISA ANA HEP-2 Aesku, Inc. | LJM |
| May 12, 2004 | K040463 | AESKULISA CARDIOLIPIN AGM Aesku, Inc. | MID |
| Dec 16, 2003 | K032469 | AESKULISA ANA 8PRO Aesku, Inc. | LLL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||