The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Biorapid Mononucleosis.
| Device ID | K030215 |
| 510k Number | K030215 |
| Device Name: | BIORAPID MONONUCLEOSIS |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-02-24 |
| Summary: | summary |