510(k) K102419
K102419 is an FDA 510(k) premarket notification submitted by Wallac Oy, Subsidiary of Perkinelmer for the device "GSP NEONATAL IRT KIT (3306-001U)". The FDA issued a decision of Substantially Equivalent on December 16, 2010. The device falls under product code JNO (N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin), a Class I device regulated under 21 CFR 862.1725. Wallac Oy, Subsidiary of Perkinelmer has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2010
- Date Received
- August 25, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
- Device Class
- Class I
- Regulation Number
- 862.1725
- Review Panel
- CH
- Submission Type