K190335 is an FDA 510(k) clearance for the GSP Neonatal Total Galactose kit. This device is classified as a Enzymatic Methods, Galactose (Class I - General Controls, product code JIA).
Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on November 6, 2019, 265 days after receiving the submission on February 14, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1310.
| 510(k) Number | K190335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2019 |
| Decision Date | November 06, 2019 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIA - Enzymatic Methods, Galactose |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1310 |