The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Monocol/lex-im Test.
| Device ID | K972457 |
| 510k Number | K972457 |
| Device Name: | MONOCOL/LEX-IM TEST |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | David Mycock |
| Correspondent | David Mycock IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-12-01 |