The following data is part of a premarket notification filed by Perkinelmer, Inc. with the FDA for Gsp Neonatalgalt Kit, Model 3303-001u.
| Device ID | K100101 |
| 510k Number | K100101 |
| Device Name: | GSP NEONATALGALT KIT, MODEL 3303-001U |
| Classification | Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase |
| Applicant | PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Contact | Kay Taylor |
| Correspondent | Kay Taylor PERKINELMER, INC. 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Product Code | KQP |
| CFR Regulation Number | 862.1315 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-13 |
| Decision Date | 2010-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147321704 | K100101 | 000 |