FDA product code JJB: Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JJB is the FDA product code for azo-dyes, colorimetric, bilirubin & its conjugates (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1115 and reviewed by the Clinical Chemistry panel. FDA has cleared 5 510(k) submissions under JJB, from 5 different applicants. The average 510(k) review took 115 days (median 92).
Classification
| Field | Value |
|---|---|
| Device name | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) |
| Device class | Class I |
| Regulation | 21 CFR 862.1115 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JJB clearance
Top JJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Teco Diagnostics | 1 | 1995-04-24 |
| Genesis Labs, Inc. | 1 | 1994-08-08 |
| Wako Chemicals USA, Inc. | 1 | 1987-09-22 |
| Amatech International, Inc. | 1 | 1986-12-04 |
| Syn-Kit, Inc. | 1 | 1984-01-11 |
Most recent JJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943436 | Teco Diagnostics | URINE REAGENT STRIPS-8 PARAMETERS | 1995-04-24 | 280 |
| K943008 | Genesis Labs, Inc. | BIOSCAN REAGENT STRIPS | 1994-08-08 | 45 |
| K873553 | Wako Chemicals USA, Inc. | WAKO(TM) PRETEST 8A | 1987-09-22 | 25 |
| K862806 | Amatech International, Inc. | URINE DIAGNOSTIC REAGENT STRIPS | 1986-12-04 | 134 |
| K833521 | Syn-Kit, Inc. | REAGENT TESTS STRIP COMBINATIONS | 1984-01-11 | 92 |
Recalls for JJB devices
openFDA lists no recalls for product code JJB.
Frequently asked questions
What is FDA product code JJB?
JJB is the FDA product code for azo-dyes, colorimetric, bilirubin & its conjugates (urinary, non-quant.). It is a Class I device, regulated under 21 CFR 862.1115 and reviewed by the Clinical Chemistry panel.
What device class is JJB?
Class I, regulation 21 CFR 862.1115. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JJB?
Across 5 cleared submissions the average was 115 days from receipt to decision (median 92).
Which companies have the most JJB clearances?
Teco Diagnostics (1); Genesis Labs, Inc. (1); Wako Chemicals USA, Inc. (1); Amatech International, Inc. (1); Syn-Kit, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JJB
- Run a recall and safety report across every JJB manufacturer
- Watch product code JJB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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