JJB
5 FDA 510(k) clearances · Product code
92 daysmedian time to decision
280 days90th percentile
5clearances measured
FDA profile
- Official device name
- Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1115
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| URINE REAGENT STRIPS-8 PARAMETERS (K943436) | Teco Diagnostics | 1995-04-24 |
| BIOSCAN REAGENT STRIPS (K943008) | Genesis Labs, Inc. | 1994-08-08 |
| WAKO(TM) PRETEST 8A (K873553) | Wako Chemicals USA, Inc. | 1987-09-22 |
| URINE DIAGNOSTIC REAGENT STRIPS (K862806) | Amatech International, Inc. | 1986-12-04 |
| REAGENT TESTS STRIP COMBINATIONS (K833521) | Syn-Kit, Inc. | 1984-01-11 |
Track JJB automatically
Every clearance here is in the API, with alerts when new ones post.