The following data is part of a premarket notification filed by Perkinelmer Inc. with the FDA for Gsp Neonatal Total Galactose Kit.
| Device ID | K190335 |
| 510k Number | K190335 |
| Device Name: | GSP Neonatal Total Galactose Kit |
| Classification | Enzymatic Methods, Galactose |
| Applicant | PerkinElmer Inc. 940 Winter Street Waltham, MA 02451 |
| Contact | Brian Ciccariello |
| Correspondent | Brian Ciccariello PerkinElmer Inc. 940 Winter Street Waltham, MA 02451 |
| Product Code | JIA |
| CFR Regulation Number | 862.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-14 |
| Decision Date | 2019-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147367917 | K190335 | 000 |