NUCLITRYP(TM)(I125)-HUMAN Pancrea Cath Try Rad Kit
FDA 510(k) K932406 · Nuclear Diagnostics, Inc.
510(k) numberK932406
Submission
- Device name
- NUCLITRYP(TM)(I125)-HUMAN Pancrea Cath Try Rad Kit
- Applicant
- Nuclear Diagnostics, Inc.
Northbrook, IL, US - Received
- May 13, 1993
- Decision date
- December 2, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
| 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 |
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| K923917 | Elipase Human Pancreatic Lipase EnzymeimmunoassayCHI · Traditional | 02/25/1994SE |
| K872177 | Tipsep-Cortisol Ria Diagnostic KitCGR · Traditional | 06/17/1987SE |
| K862312 | Enzlipase, Enzymatic Lipase KitCHI · Traditional | 09/26/1986SE |
| K860472 | Nuclear Laser Alignment System for Cardic StressIWE · Traditional | 07/03/1986SE |
| K861735 | Tipsep-Tbg AssayCEE · Traditional | 06/13/1986SE |
| K852291 | Tipsep Digoxin RiaDNL · Traditional | 06/25/1985SE |
| K833713 | Serum Thyrotropin Assay Kit, Tipsep-JLW · Traditional | 12/29/1983SE |
| K823860 | Nuclipase (I125) Pancreatic LipaseCET · Traditional | 04/18/1983SE |
Questions and answers
When was NUCLITRYP(TM)(I125)-HUMAN Pancrea Cath Try Rad Kit cleared by the FDA?
NUCLITRYP(TM)(I125)-HUMAN Pancrea Cath Try Rad Kit (K932406) received a 510(k) decision of Substantially Equivalent on December 2, 1993, 203 days after the submission was received.
What is the product code of K932406?
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.