FDA product code GJE: Tray, Blood Collection
GJE is the FDA product code for tray, blood collection. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under GJE, from 5 different applicants. The average 510(k) review took 106 days (median 35). FDA has posted 1 recall for GJE devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tray, Blood Collection |
| Device class | Class II |
| Regulation | 21 CFR 862.1675 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GJE clearance
Top GJE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 1978-03-30 |
| Customed, Inc. | 1 | 1996-09-27 |
| J.J. Skinner, Inc. | 1 | 1994-04-11 |
| Bio/Data Corp. | 1 | 1977-01-10 |
| Concord Laboratories, Inc. | 1 | 1976-07-16 |
Most recent GJE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962596 | Customed, Inc. | CUSTOMED BLOOD EXTRACTION KIT | 1996-09-27 | 87 |
| K925468 | J.J. Skinner, Inc. | JJ SKINNER CAREKITS(TM) BLOOD COLLECTION KIT | 1994-04-11 | 529 |
| K780303 | Bd Becton Dickinson Vacutainer Systems Preanalytic | AUTO ISO-FILTER COLLECTION TUBE CAP | 1978-03-30 | 35 |
| K771489 | Bd Becton Dickinson Vacutainer Systems Preanalytic | RTERIAL BLOOD SAMPLING KIT | 1977-08-22 | 17 |
| K771370 | Bd Becton Dickinson Vacutainer Systems Preanalytic | ICROTAINEO BRAND TUBE | 1977-08-03 | 9 |
Recalls for GJE devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-11-01.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code GJE?
GJE is the FDA product code for tray, blood collection. It is a Class II device, regulated under 21 CFR 862.1675 and reviewed by the Clinical Chemistry panel.
What device class is GJE?
Class II, regulation 21 CFR 862.1675. Typical premarket route: 510(k).
How long does a 510(k) take for product code GJE?
Across 7 cleared submissions the average was 106 days from receipt to decision (median 35).
Which companies have the most GJE clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (3); Customed, Inc. (1); J.J. Skinner, Inc. (1); Bio/Data Corp. (1); Concord Laboratories, Inc. (1).
Have GJE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-11-01.
Next steps
- Run an FDA pathway report with predicate devices for product code GJE
- Run a recall and safety report across every GJE manufacturer
- Watch product code GJE 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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