JQXClass I
Nephelometer, For Clinical Use
21 CFR 862.2700 / Clinical Chemistry
JQX is the FDA product code for Nephelometer, For Clinical Use, a class I device type, regulated under 21 CFR 862.2700. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- JQX
- Device name
- Nephelometer, For Clinical Use
- Regulation
- 21 CFR 862.2700
- Device class
- Class I
- Review panel
- Clinical Chemistry
- 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
- 4
Clearances, product code JQX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 4 |
| 1979 | 2 |
| 1980 | 2 |
| 1985 | 2 |
| 1989 | 1 |
| 1992 | 1 |
| 1996 | 1 |
Applicants with the most clearances
Product code JQX| Applicant | Clearances |
|---|---|
| Abbott Medical | 2 |
| Beckman Instruments, Inc. | 2 |
| Biovation, Inc. | 2 |
| J.T. Baker Chemical Co. | 2 |
| Dynatech Corp. | 1 |
| G.D. Searle and Co. | 1 |
| Hyland Therapeutic Div., Travenol Laboratories | 1 |
| Kallestad Laboratories, Inc. | 1 |
| Organon LLC | 1 |
| Seradyn, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
- Becton Dickinson & Co
- DIAMOND DIAGNOSTICS Inc
- GFS Chemicals, Inc
- Healgen Scientific LLC
- Plexus Manufacturing Sdn.Bhd.
- Remel Inc
- Siemens Healthcare Diagnostics Inc.
- Strumed Solutions Private Limited
- Trek Diagnostic Systems, Ltd.
- Zhejiang Orient Gene Biotech
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.
