FDA product code JBL: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
JBL is the FDA product code for glucose-6-phosphate dehydrogenase (erythrocytic), quantitative. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under JBL, from 2 different applicants. The average 510(k) review took 46 days (median 46). FDA has posted 2 recalls for JBL devices.
Classification
| Field | Value |
|---|---|
| Device name | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative |
| Device class | Class II |
| Regulation | 21 CFR 864.7360 |
| 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 JBL clearance
Top JBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Astoria-Pacific, Inc. | 1 | 1999-05-11 |
| Sigma Chemical Co. | 1 | 1979-03-15 |
Most recent JBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990957 | Astoria-Pacific, Inc. | ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K | 1999-05-11 | 50 |
| K790211 | Sigma Chemical Co. | DEHYDROGENOSE, GLUCOSE PHOSPHATE | 1979-03-15 | 43 |
Recalls for JBL devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-03.
| Year | Recalls |
|---|---|
| 2019 | 2 |
Frequently asked questions
What is FDA product code JBL?
JBL is the FDA product code for glucose-6-phosphate dehydrogenase (erythrocytic), quantitative. It is a Class II device, regulated under 21 CFR 864.7360 and reviewed by the Hematology panel.
What device class is JBL?
Class II, regulation 21 CFR 864.7360. Typical premarket route: 510(k).
How long does a 510(k) take for product code JBL?
Across 2 cleared submissions the average was 46 days from receipt to decision (median 46).
Which companies have the most JBL clearances?
Astoria-Pacific, Inc. (1); Sigma Chemical Co. (1).
Have JBL devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2019-04-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JBL
- Run a recall and safety report across every JBL manufacturer
- Watch product code JBL 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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