The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Neonatal Chemistry System, Galactose Test Kit.
| Device ID | K950481 |
| 510k Number | K950481 |
| Device Name: | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT |
| Classification | Enzymatic Methods, Galactose |
| Applicant | ISOLAB, INC. BOX 4350 Akron, OH 44321 |
| Contact | Janet Perkins |
| Correspondent | Janet Perkins ISOLAB, INC. BOX 4350 Akron, OH 44321 |
| Product Code | JIA |
| CFR Regulation Number | 862.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-03 |
| Decision Date | 1996-02-01 |