The following data is part of a premarket notification filed by Thera-test Laboratories Inc. with the FDA for Theratest El-beta2gpi (igm-igg-iga), Theratest El--beta2gpi Scr.
| Device ID | K092757 |
| 510k Number | K092757 |
| Device Name: | THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR |
| Classification | System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Applicant | THERA-TEST LABORATORIES INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Contact | Marius Teodorescu |
| Correspondent | Marius Teodorescu THERA-TEST LABORATORIES INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-09 |
| Decision Date | 2009-10-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854473003286 | K092757 | 000 |
| 00854473003040 | K092757 | 000 |