The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for I.m.n. Latex.
| Device ID | K874678 |
| 510k Number | K874678 |
| Device Name: | I.M.N. LATEX |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | BIOKIT USA, INC. CORCEGA 603-605 08025 Barcelona, Spain , |
| Contact | Guixer |
| Correspondent | Guixer BIOKIT USA, INC. CORCEGA 603-605 08025 Barcelona, Spain , |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-13 |
| Decision Date | 1987-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613647001325 | K874678 | 000 |
| 00613647001318 | K874678 | 000 |
| 00613647001301 | K874678 | 000 |
| 00840733101298 | K874678 | 000 |