The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Color-monogen.
| Device ID | K012901 |
| 510k Number | K012901 |
| Device Name: | COLOR-MONOGEN |
| 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 | 2001-08-29 |
| Decision Date | 2001-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613647001202 | K012901 | 000 |
| 00613647001196 | K012901 | 000 |