Autodelfia Neonatal Irt Kit
FDA 510(k) K110274 · Wallac Oy, A Subsidiary of Perkinelmer, Inc.
510(k) numberK110274
Submission
- Device name
- Autodelfia Neonatal Irt Kit
- Applicant
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Waltham, MA, US - Received
- January 31, 2011
- Decision date
- June 10, 2011
- 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 |
|---|---|---|---|
| K102419 | GSP Neonatal Irt Kit (3306-001U)JNO · Traditional | Wallac Oy, Subsidiary of Perkinelmer | 12/16/2010SE |
| 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.
Questions and answers
When was Autodelfia Neonatal Irt Kit cleared by the FDA?
Autodelfia Neonatal Irt Kit (K110274) received a 510(k) decision of Substantially Equivalent on June 10, 2011, 130 days after the submission was received.
What is the product code of K110274?
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.