The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Lithium Regent Model Tr66056 / Lithium Standard Tr66901.
| Device ID | K003583 |
| 510k Number | K003583 |
| Device Name: | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 |
| Classification | Assay, Porphyrin, Spectrophotometry, Lithium |
| Applicant | TRACE AMERICA, INC. 845 AVE. G EAST Arlington, TX 76011 |
| Contact | Thomas Dollar |
| Correspondent | Thomas Dollar TRACE AMERICA, INC. 845 AVE. G EAST Arlington, TX 76011 |
| Product Code | NDW |
| CFR Regulation Number | 862.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2001-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845275005424 | K003583 | 000 |
| 00845275005417 | K003583 | 000 |
| 00845275004526 | K003583 | 000 |
| 00845275003352 | K003583 | 000 |
| 00845275003345 | K003583 | 000 |
| 00845275000429 | K003583 | 000 |