JJGClass I
Analyzer, Chemistry, Centrifugal, For Clinical Use
21 CFR 862.2140 / Clinical Chemistry
JJG is the FDA product code for Analyzer, Chemistry, Centrifugal, For Clinical Use, a class I device type, regulated under 21 CFR 862.2140. As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- JJG
- Device name
- Analyzer, Chemistry, Centrifugal, For Clinical Use
- Regulation
- 21 CFR 862.2140
- 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
- 30
- Ingested recalls
- 1
Clearances, product code JJG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 3 |
| 1981 | 1 |
| 1983 | 4 |
| 1984 | 3 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 2 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 1 |
Applicants with the most clearances
Product code JJG| Applicant | Clearances |
|---|---|
| Roche Diagnostic Systems, Inc. | 4 |
| Union Carbide Corp. | 4 |
| Abaxis Inc | 2 |
| American Scientific Products | 2 |
| Baker Instructions Corp. | 2 |
| Beckman Instruments, Inc. | 2 |
| Instrumentation Laboratory Co. | 2 |
| Abbott Medical | 1 |
| Autogenic Systems | 1 |
| Clinical Diagnostics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abaxis Inc
- Accuster Technologies Pvt. Ltd.
- Bialex Lab
- DIAMOND DIAGNOSTICS Inc
- Globe Scientific, LLC
- Hemagen Diagnostics, Inc.
- Heuer International (A division of GST Corporation Limited)
- Huzhou Junda Industry Co., Ltd.
- Labotek Group Corp
- Nanning Tecbod Biological Technology Co.,Ltd
- Q-Line Biotech Limited
- Silfradent SRL
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What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
