FDA product code GHY: Hematocrit, Tube, Rack, Sealer, Holder
GHY is the FDA product code for hematocrit, tube, rack, sealer, holder. It is a Class II device, regulated under 21 CFR 864.6400 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GHY, from 2 different applicants. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Hematocrit, Tube, Rack, Sealer, Holder |
| Device class | Class II |
| Regulation | 21 CFR 864.6400 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GHY clearance
Top GHY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Norfolk Scientific, Inc. | 1 | 1988-08-18 |
| Helps Products, Inc. | 1 | 1988-05-13 |
Most recent GHY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883185 | Norfolk Scientific, Inc. | SAFECRIT PLASTIC MICROHEMATOCRIT TUBES | 1988-08-18 | 21 |
| K881186 | Helps Products, Inc. | MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL | 1988-05-13 | 53 |
Recalls for GHY devices
openFDA lists no recalls for product code GHY.
Frequently asked questions
What is FDA product code GHY?
GHY is the FDA product code for hematocrit, tube, rack, sealer, holder. It is a Class II device, regulated under 21 CFR 864.6400 and reviewed by the Hematology panel.
What device class is GHY?
Class II, regulation 21 CFR 864.6400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GHY?
Across 2 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most GHY clearances?
Norfolk Scientific, Inc. (1); Helps Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GHY
- Run a recall and safety report across every GHY manufacturer
- Watch product code GHY 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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