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 |