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 |