LFRClass II
Glucose Dehydrogenase, Glucose
21 CFR 862.1345 / Clinical Chemistry
LFR is the FDA product code for Glucose Dehydrogenase, Glucose, a class II device type, regulated under 21 CFR 862.1345. As of , FDA records hold 73 510(k) clearances under this code, the most recent dated , and 51 recalls.
Classification record
- Product code
- LFR
- Device name
- Glucose Dehydrogenase, 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
- 73
- Ingested recalls
- 51
Clearances, product code LFR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 2 |
| 1981 | 3 |
| 1982 | 3 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1995 | 2 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 4 |
| 1999 | 2 |
| 2000 | 5 |
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 6 |
| 2012 | 13 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 1 |
Applicants with the most clearances
Product code LFR| Applicant | Clearances |
|---|---|
| Roche Diagnostics GmbH | 13 |
| Abbott Medical | 9 |
| Boehringer Mannheim Corp. | 9 |
| Eps Bio Technology Corp. | 6 |
| Medrad, Inc. | 4 |
| HemoCue AB | 4 |
| Taidoc Technology Corporation | 4 |
| EMD Millipore Corporation | 3 |
| Harleco | 3 |
| HMD Biomedical, Inc. | 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.