MRI Neo-Tryp Trypsin Ria
FDA 510(k) K883011 · Microbiological Research Corp.
510(k) numberK883011
Submission
- Device name
- MRI Neo-Tryp Trypsin Ria
- Applicant
- Microbiological Research Corp.
Laguna Hills, CA, US - Received
- July 19, 1988
- Decision date
- April 26, 1989
- 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 |
| 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 |
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| K861121 | The Golden Quad Test (Ebv)GNP · Traditional | 02/02/1987SE |
| K861120 | The Golden Quad Test (HSV)GQO · Traditional | 02/02/1987SE |
| K860450 | The Cmv-Igm TestLKQ · Traditional | 05/13/1986SE |
| K843138 | CMV TestLIN · Traditional | 01/29/1985SE |
| K821018 | Antihuman Igg Globulin Fitc LabeledDEW · Traditional | 04/29/1982SE |
| K821019 | Phosphate Buffered Clycerol Mounting FluLEB · Traditional | 04/26/1982SE |
| K803175 | Rubella Virus Serological ReagentsLFX · Traditional | 01/29/1981SE |
| K803134 | Toxoplasma Gondii Serological ReagentsGLZ · Traditional | 01/29/1981SE |
Questions and answers
When was MRI Neo-Tryp Trypsin Ria cleared by the FDA?
MRI Neo-Tryp Trypsin Ria (K883011) received a 510(k) decision of Substantially Equivalent on April 26, 1989, 281 days after the submission was received.
What is the product code of K883011?
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.