K190266 is an FDA 510(k) clearance for the NeoLSD MSMS Kit. This device is classified as a Alpha-d-galactosidase A (gla) Newborn Screening Test System (Class II - Special Controls, product code PQW).
Submitted by Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on May 3, 2019, 84 days after receiving the submission on February 8, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1488. For Quantitative Measurement Of The Activity Of Alpha-d-galactosidase A (gla) From Newborn Dried Blood Spot Specimens..
| 510(k) Number | K190266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2019 |
| Decision Date | May 03, 2019 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | PQW - Alpha-d-galactosidase A (gla) Newborn Screening Test System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1488 |
| Definition | For Quantitative Measurement Of The Activity Of Alpha-d-galactosidase A (gla) From Newborn Dried Blood Spot Specimens. |