The following data is part of a premarket notification filed by Pro-lab Diagnostics with the FDA for Transystem Amies W/o Charcoal.
| Device ID | K924329 |
| 510k Number | K924329 |
| Device Name: | TRANSYSTEM AMIES W/O CHARCOAL |
| Classification | Device, Specimen Collection |
| Applicant | PRO-LAB DIAGNOSTICS 20 MURAL ST. RICHMOND HILL Ontario, CA |
| Contact | Robert Rae |
| Correspondent | Robert Rae PRO-LAB DIAGNOSTICS 20 MURAL ST. RICHMOND HILL Ontario, CA |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-27 |
| Decision Date | 1992-12-24 |