FQZClass I
Thermometer, Clinical Color Change
21 CFR 880.2900 / General Hospital
FQZ is the FDA product code for Thermometer, Clinical Color Change, a class I device type, regulated under 21 CFR 880.2900. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- FQZ
- Device name
- Thermometer, Clinical Color Change
- Regulation
- 21 CFR 880.2900
- Device class
- Class I
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 14
- Ingested recalls
- 2
Clearances, product code FQZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1979 | 2 |
| 1982 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 2012 | 1 |
Applicants with the most clearances
Product code FQZ| Applicant | Clearances |
|---|---|
| Info-Chem | 3 |
| Airlife, Inc. | 1 |
| Brymill Cryogenic Cystems | 1 |
| Deroyal Critical Care, Div. Deroyal Technologies | 1 |
| Franklin Diagnostics, Inc. | 1 |
| Healthcheck Corp. | 1 |
| Joel R.L. Ehren Kranz | 1 |
| Kyowa Medex Co., Ltd. | 1 |
| Organon LLC | 1 |
| Pymah Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Acme United Corp.
- Aero Healthcare
- American Thermal Instruments, LLC
- Beijing Zksk Technology Co., Ltd.
- Boen Healthcare Co., Ltd.
- Care Line, Inc.
- China (Shenyang) Med-Land Imp/EXP Corp., Ltd.
- Cintas Corporation
- Coast Imports LLC
- Gfa Production Inc
- GFA Production Xiamen Co., Ltd.
- Guangdong Genial Technology Co., Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
