JILClass II
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
21 CFR 862.1340 / Clinical Chemistry
JIL is the FDA product code for Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a class II device type, regulated under 21 CFR 862.1340. As of , FDA records hold 81 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- JIL
- Device name
- Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Regulation
- 21 CFR 862.1340
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 81
- Ingested recalls
- 7
Clearances, product code JIL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 14 |
| 1986 | 3 |
| 1987 | 2 |
| 1990 | 2 |
| 1993 | 7 |
| 1994 | 3 |
| 1995 | 4 |
| 1996 | 3 |
| 1997 | 2 |
| 1999 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 4 |
| 2007 | 3 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 4 |
| 2019 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code JIL| Applicant | Clearances |
|---|---|
| Syn-Kit, Inc. | 11 |
| Tanabe U.S.A., Inc. | 8 |
| Teco Diagnostics | 8 |
| Kyoto Diagnostics, Inc. | 4 |
| Analyticon Biotechnologies AG | 3 |
| Arkray, Inc. | 3 |
| Miles Laboratories, Inc. | 3 |
| Roche Diagnostics GmbH | 3 |
| Yd Pharmaceutical Corp. | 3 |
| American Diagnostic Corp. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.