The following data is part of a premarket notification filed by Theratest Laboratories, Inc. with the FDA for The Theratest El-ana Profiles: Anti-centromere.
Device ID | K024031 |
510k Number | K024031 |
Device Name: | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE |
Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
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 | LJM |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-06 |
Decision Date | 2003-02-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00854473003170 | K024031 | 000 |