The following data is part of a premarket notification filed by Aesku, Inc with the FDA for Aeskulska Beta2-glyco-a.
| Device ID | K062217 |
| 510k Number | K062217 |
| Device Name: | AESKULSKA BETA2-GLYCO-A |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | AESKU, INC 8880 NORTHWEST 18TH TERRACE Miami, FL 33172 |
| Contact | David Bell |
| Correspondent | David Bell AESKU, INC 8880 NORTHWEST 18TH TERRACE Miami, FL 33172 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-01 |
| Decision Date | 2006-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250289503099 | K062217 | 000 |
| 04250289500852 | K062217 | 000 |
| 04250289500869 | K062217 | 000 |
| 04250289500951 | K062217 | 000 |
| 04250289502825 | K062217 | 000 |
| 04250289502832 | K062217 | 000 |
| 04250289502849 | K062217 | 000 |
| 04250289503075 | K062217 | 000 |
| 04250289503082 | K062217 | 000 |
| B24235B2SHUE010 | K062217 | 000 |