Submission Details
| 510(k) Number | K102419 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 25, 2010 |
| Decision Date | December 16, 2010 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
GSP NEONATAL IRT KIT (3306-001U)
Dec 2010
Decision
113d
Days
Class 1
Risk
About This 510(k) Submission
K102419 is an FDA 510(k) clearance for the GSP NEONATAL IRT KIT (3306-001U), a N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (Class I — General Controls, product code JNO), submitted by Wallac Oy, Subsidiary of Perkinelmer (Waltham, US). The FDA issued a Cleared decision on December 16, 2010, 113 days after receiving the submission on August 25, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1725.
Device Classification
| Product Code | JNO — N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1725 |
Manufacturer
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