The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for El-acl Screen; El-acl Igm, Igg, Iga.
| Device ID | K060176 |
| 510k Number | K060176 |
| Device Name: | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Contact | Marius Teodorescu |
| Correspondent | Marius Teodorescu THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Product Code | MID |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-23 |
| Decision Date | 2006-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854473003200 | K060176 | 000 |
| 00854473003194 | K060176 | 000 |