GSP Neonatal Irt Kit (3306-001U)
FDA 510(k) K102419 · Wallac Oy, Subsidiary of Perkinelmer
510(k) numberK102419
Submission
- Device name
- GSP Neonatal Irt Kit (3306-001U)
- Applicant
- Wallac Oy, Subsidiary of Perkinelmer
Waltham, MA, US - Received
- August 25, 2010
- Decision date
- December 16, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JNO – N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1725
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JNO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110274 | Autodelfia Neonatal Irt KitJNO · Traditional | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 06/10/2011SE |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN Pancrea Cath Try Rad KitJNO · Traditional | Nuclear Diagnostics, Inc. | 12/02/1993SE |
| K883011 | MRI Neo-Tryp Trypsin RiaJNO · Traditional | Microbiological Research Corp. | 04/26/1989SE |
| K861097 | Trypsin Ria KitJNO · Traditional | Microanalytic Research, Inc. | 05/29/1986SE |
| K811805 | Trypin (125I) Ria KitJNO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/31/1981SE |
| K791202 | Ria Kit for TrypsinJNO · Traditional | Cis Radiopharmaceuticals, Inc. | 11/05/1979SE |
More from Cis Radiopharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173568 | NeoBase 2 Non-derivatized MSMS KitNQL · Traditional | 09/04/2018SE |
Questions and answers
When was GSP Neonatal Irt Kit (3306-001U) cleared by the FDA?
GSP Neonatal Irt Kit (3306-001U) (K102419) received a 510(k) decision of Substantially Equivalent on December 16, 2010, 113 days after the submission was received.
What is the product code of K102419?
The FDA product code is JNO – N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin, a Class I (low risk) device regulated under 21 CFR 862.1725.