The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Accuwell Phenylalanine Assay.
| Device ID | K974047 |
| 510k Number | K974047 |
| Device Name: | ACCUWELL PHENYLALANINE ASSAY |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| Applicant | NEOMETRICS, INC. 104 BELLEROSE AVE. East Northport, NY 11731 |
| Contact | David Schwartz |
| Correspondent | David Schwartz NEOMETRICS, INC. 104 BELLEROSE AVE. East Northport, NY 11731 |
| Product Code | JNB |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-24 |
| Decision Date | 1997-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000601 | K974047 | 000 |