Trypsin Ria Kit
FDA 510(k) K861097 · Microanalytic Research, Inc.
510(k) numberK861097
Submission
- Device name
- Trypsin Ria Kit
- Applicant
- Microanalytic Research, Inc.
Laguna Hills, CA, US - Received
- March 24, 1986
- Decision date
- May 29, 1986
- 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 |
| 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 |
|---|---|---|
| K820741 | MR1 Lutropin Ria KitCEP · Traditional | 04/14/1982SE |
| K820740 | MR1 Follitropin Ria KitCGJ · Traditional | 04/06/1982SE |
| K813516 | MRI Tobramycin Ria KitKLB · Traditional | 12/29/1981SE |
| K812394 | MRI Gentamicin Ria KitDJB · Traditional | 09/08/1981SE |
| K810949 | MRI Prolactin Ria KitCFT · Traditional | 07/10/1981SE |
| K802754 | Immunoreactive Estriol Ria KitCGI · Traditional | 01/21/1981SE |
| K801491 | MRI Hcg-Beta Ria Kit Cat. #MR-10100JHI · Traditional | 08/13/1980SE |
Questions and answers
When was Trypsin Ria Kit cleared by the FDA?
Trypsin Ria Kit (K861097) received a 510(k) decision of Substantially Equivalent on May 29, 1986, 66 days after the submission was received.
What is the product code of K861097?
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.