FDA product code JBB: Solubility, Hemoglobin, Abnormal
JBB is the FDA product code for solubility, hemoglobin, abnormal. It is a Class II device, regulated under 21 CFR 864.7825 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under JBB, from 2 different applicants. The average 510(k) review took 64 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Solubility, Hemoglobin, Abnormal |
| Device class | Class II |
| Regulation | 21 CFR 864.7825 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JBB clearance
Top JBB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Histo-Med, Inc. | 1 | 1993-08-16 |
| Simmler, Inc. | 1 | 1989-11-29 |
Most recent JBB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932872 | Histo-Med, Inc. | SICKLE CELL TEST KIT | 1993-08-16 | 63 |
| K895745 | Simmler, Inc. | SICKLE CELL SOLUBILITY TEST KIT | 1989-11-29 | 64 |
Recalls for JBB devices
openFDA lists no recalls for product code JBB.
Frequently asked questions
What is FDA product code JBB?
JBB is the FDA product code for solubility, hemoglobin, abnormal. It is a Class II device, regulated under 21 CFR 864.7825 and reviewed by the Hematology panel.
What device class is JBB?
Class II, regulation 21 CFR 864.7825. Typical premarket route: 510(k).
How long does a 510(k) take for product code JBB?
Across 2 cleared submissions the average was 64 days from receipt to decision (median 64).
Which companies have the most JBB clearances?
Histo-Med, Inc. (1); Simmler, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JBB
- Run a recall and safety report across every JBB manufacturer
- Watch product code JBB 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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