The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Accuwell Total Galactose, Model 6010-egal.
| Device ID | K991498 |
| 510k Number | K991498 |
| Device Name: | ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL |
| Classification | Enzymatic Methods, Galactose |
| 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 | JIA |
| CFR Regulation Number | 862.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-29 |
| Decision Date | 1999-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000199 | K991498 | 000 |
| 00725609000595 | K991498 | 000 |