Trypin (125I) Ria Kit
FDA 510(k) K811805 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK811805
Submission
- Device name
- Trypin (125I) Ria Kit
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- June 24, 1981
- Decision date
- August 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| K791202 | Ria Kit for TrypsinJNO · Traditional | Cis Radiopharmaceuticals, Inc. | 11/05/1979SE |
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Questions and answers
When was Trypin (125I) Ria Kit cleared by the FDA?
Trypin (125I) Ria Kit (K811805) received a 510(k) decision of Substantially Equivalent on August 31, 1981, 68 days after the submission was received.
What is the product code of K811805?
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.