The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for Theratest El-ana Profiles.
| Device ID | K051066 |
| 510k Number | K051066 |
| Device Name: | THERATEST EL-ANA PROFILES |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Contact | Marius Tedorescu |
| Correspondent | Marius Tedorescu THERATEST LABORATORIES, INC. 1111 N. MAIN ST. Lombard, IL 60148 |
| Product Code | LKP |
| Subsequent Product Code | LJM |
| Subsequent Product Code | LKO |
| Subsequent Product Code | LLL |
| Subsequent Product Code | LRM |
| Subsequent Product Code | MQA |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-26 |
| Decision Date | 2005-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854473003309 | K051066 | 000 |
| 00854473003354 | K051066 | 000 |
| 00854473003026 | K051066 | 000 |
| 00854473003071 | K051066 | 000 |
| 00854473003088 | K051066 | 000 |
| 00854473003095 | K051066 | 000 |
| 00854473003101 | K051066 | 000 |
| 00854473003118 | K051066 | 000 |
| 00854473003125 | K051066 | 000 |
| 00854473003149 | K051066 | 000 |
| 00854473003156 | K051066 | 000 |
| 00854473003293 | K051066 | 000 |
| 00854473003347 | K051066 | 000 |