K100101 is an FDA 510(k) clearance for the GSP NEONATALGALT KIT, MODEL 3303-001U. This device is classified as a Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase (Class II - Special Controls, product code KQP).
Submitted by Perkinelmer, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 11, 2010, 149 days after receiving the submission on January 13, 2010.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1315.
| 510(k) Number | K100101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2010 |
| Decision Date | June 11, 2010 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KQP - Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1315 |