The following data is part of a premarket notification filed by Adams Meditech Llc with the FDA for Adh 200 Analyzer Software.
| Device ID | K143449 |
| 510k Number | K143449 |
| Device Name: | ADH 200 Analyzer Software |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ADAMS MEDITECH LLC 17890 Castleton Street, Suite 302 City Of Industry, CA 91748 |
| Contact | Cecilia L. Yu |
| Correspondent | Cecilia L. Yu LAW OFFICES OF CECILIA L. YU & ASSOCIATES 17890 CASTLETON STREET, SUITE 302 City Of Industry, CA 91748 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-02 |
| Decision Date | 2015-06-26 |