The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for The Theratest El-b2gp1 (igm, Igg, Iga) And El-b2gp1scr.
| Device ID | K972790 |
| 510k Number | K972790 |
| Device Name: | THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Contact | Marius Teodorescu |
| Correspondent | Marius Teodorescu THERATEST LABORATORIES, INC. 2201 WEST CAMPBELL PARK DR. Chicago, IL 60612 -3501 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1997-12-05 |