The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for Theratest El-ttg Iga/igg And Theratest El-glia Iga/igg Test Systems.
| Device ID | K071692 |
| 510k Number | K071692 |
| Device Name: | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS |
| Classification | Autoantibodies, Endomysial(tissue Transglutaminase) |
| 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 | MVM |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-20 |
| Decision Date | 2007-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854473003224 | K071692 | 000 |
| 00854473003217 | K071692 | 000 |