FDA product code GJG: Pipette, Quantitative, Hematology
GJG is the FDA product code for pipette, quantitative, hematology. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel. FDA has cleared 4 510(k) submissions under GJG, from 4 different applicants. The average 510(k) review took 22 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Pipette, Quantitative, Hematology |
| Device class | Class I |
| Regulation | 21 CFR 864.6160 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GJG clearance
Top GJG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Kendall Company Div. of Tyco Healthcare Group | 1 | 1983-04-28 |
| Hillwood Corp. | 1 | 1978-11-15 |
| Owens-Illinois, Inc. | 1 | 1978-03-09 |
| Dade, Baxter Travenol Diagnostics, Inc. | 1 | 1976-10-29 |
Most recent GJG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831079 | The Kendall Company Div. of Tyco Healthcare Group | LIQUIPETTE | 1983-04-28 | 24 |
| K781891 | Hillwood Corp. | PIPETTES, PLASTIC DISPOSABLE | 1978-11-15 | 7 |
| K780237 | Owens-Illinois, Inc. | DISPOSABLE CONTROLLED DROP PASTEUR PIPET | 1978-03-09 | 24 |
| K760719 | Dade, Baxter Travenol Diagnostics, Inc. | UNIFORM DROP SIZE PASTEUR TYPE PIPETS | 1976-10-29 | 32 |
Recalls for GJG devices
openFDA lists no recalls for product code GJG.
Frequently asked questions
What is FDA product code GJG?
GJG is the FDA product code for pipette, quantitative, hematology. It is a Class I device, regulated under 21 CFR 864.6160 and reviewed by the Hematology panel.
What device class is GJG?
Class I, regulation 21 CFR 864.6160. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GJG?
Across 4 cleared submissions the average was 22 days from receipt to decision (median 24).
Which companies have the most GJG clearances?
The Kendall Company Div. of Tyco Healthcare Group (1); Hillwood Corp. (1); Owens-Illinois, Inc. (1); Dade, Baxter Travenol Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GJG
- Run a recall and safety report across every GJG manufacturer
- Watch product code GJG 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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