FDA product code JBX: Aggregrometer, Platelet
JBX is the FDA product code for aggregrometer, platelet. It is a Class II device, regulated under 21 CFR 864.6675 and reviewed by the Hematology panel. FDA has cleared 12 510(k) submissions under JBX, from 7 different applicants. The average 510(k) review took 68 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Aggregrometer, Platelet |
| Device class | Class II |
| Regulation | 21 CFR 864.6675 |
| 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 JBX clearance
Top JBX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chrono-Log Corp. | 5 | 1993-11-02 |
| Bio/Data Corp. | 2 | 1982-06-01 |
| Helena Laboratories | 1 | 1991-08-22 |
| Streck Laboratories, Inc. | 1 | 1988-07-01 |
| American Bioproducts Co. | 1 | 1986-10-22 |
2 more applicants have JBX clearances. See the full list in Caduvo.
Most recent JBX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932566 | Chrono-Log Corp. | AGGRO/LINK CONTROL SOFTWARE | 1993-11-02 | 159 |
| K912774 | Helena Laboratories | ARACHIDONIC ACID | 1991-08-22 | 59 |
| K881829 | Streck Laboratories, Inc. | PAT PLATELET AGGREGATION TEST | 1988-07-01 | 63 |
| K862775 | American Bioproducts Co. | ASSERACHROM B-TG KIT | 1986-10-22 | 92 |
| K851025 | Chrono-Log Corp. | AGGRO/LINK COMPUTER INTERFACE | 1985-06-12 | 93 |
Recalls for JBX devices
openFDA lists no recalls for product code JBX.
Frequently asked questions
What is FDA product code JBX?
JBX is the FDA product code for aggregrometer, platelet. It is a Class II device, regulated under 21 CFR 864.6675 and reviewed by the Hematology panel.
What device class is JBX?
Class II, regulation 21 CFR 864.6675. Typical premarket route: 510(k).
How long does a 510(k) take for product code JBX?
Across 12 cleared submissions the average was 68 days from receipt to decision (median 66).
Which companies have the most JBX clearances?
Chrono-Log Corp. (5); Bio/Data Corp. (2); Helena Laboratories (1); Streck Laboratories, Inc. (1); American Bioproducts Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JBX
- Run a recall and safety report across every JBX manufacturer
- Watch product code JBX 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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