CFRClass II
Hexokinase, Glucose
21 CFR 862.1345 / Clinical Chemistry
CFR is the FDA product code for Hexokinase, Glucose, a class II device type, regulated under 21 CFR 862.1345. As of , FDA records hold 145 510(k) clearances under this code, the most recent dated , and 22 recalls.
Classification record
- Product code
- CFR
- Device name
- Hexokinase, Glucose
- Regulation
- 21 CFR 862.1345
- 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
- 145
- Ingested recalls
- 22
Clearances, product code CFR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 3 |
| 1977 | 10 |
| 1978 | 5 |
| 1979 | 3 |
| 1980 | 7 |
| 1981 | 3 |
| 1982 | 4 |
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 3 |
| 1986 | 5 |
| 1987 | 4 |
| 1988 | 4 |
| 1989 | 5 |
| 1990 | 2 |
| 1991 | 5 |
| 1992 | 6 |
| 1993 | 5 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 5 |
| 1997 | 5 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 4 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 5 |
| 2007 | 1 |
| 2008 | 5 |
| 2009 | 3 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code CFR| Applicant | Clearances |
|---|---|
| Em Diagnostic Systems, Inc. | 7 |
| Abbott Medical | 6 |
| Harleco | 6 |
| Kulzer GmbH | 6 |
| Roche Diagnostics GmbH | 6 |
| Siemens Healthcare Diagnostics Inc. | 5 |
| Data Medical Associates, Inc. | 4 |
| Horiba Instruments Incorporated | 4 |
| EMD Millipore Corporation | 3 |
| Instrumentation Laboratory Co. | 3 |
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.