The following data is part of a premarket notification filed by Adiatec Sa with the FDA for Lacrytest.
| Device ID | K034057 |
| 510k Number | K034057 |
| Device Name: | LACRYTEST |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | ADIATEC SA 5 PASSAGE DOUARD 4 RUE DES OLIVETTES Nantes, FR 44000 |
| Contact | Joel Lesser |
| Correspondent | Joel Lesser ADIATEC SA 5 PASSAGE DOUARD 4 RUE DES OLIVETTES Nantes, FR 44000 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-30 |
| Decision Date | 2004-03-09 |
| Summary: | summary |