JJBClass I
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
21 CFR 862.1115 / Clinical Chemistry
JJB is the FDA product code for Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.), a class I device type, regulated under 21 CFR 862.1115. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JJB
- Device name
- Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- Regulation
- 21 CFR 862.1115
- 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
- 5
- Ingested recalls
- 0
Clearances, product code JJB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1994 | 1 |
| 1995 | 1 |
Applicants with the most clearances
Product code JJB| Applicant | Clearances |
|---|---|
| Amatech International, Inc. | 1 |
| Genesis Labs, Inc. | 1 |
| Syn-Kit, Inc. | 1 |
| Teco Diagnostics | 1 |
| FUJIFILM Healthcare Americas Corporation | 1 |
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.