The following data is part of a premarket notification filed by Micromass, Inc. with the FDA for Neolynx Screening Application Manager.
| Device ID | K003584 |
| 510k Number | K003584 |
| Device Name: | NEOLYNX SCREENING APPLICATION MANAGER |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| Applicant | MICROMASS, INC. 34 MAPLE ST. Milford, MA 01757 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon MICROMASS, INC. 34 MAPLE ST. Milford, MA 01757 |
| Product Code | JNB |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-20 |
| Decision Date | 2001-03-19 |