Data / Medical devices / Hematocrit, Tube, Rack, Sealer, Holder
Hematocrit, Tube, Rack, Sealer, Holder (GHY): 14 FDA-registered makers in 7 countries
14 establishments in 7 countries are registered with the FDA to make Hematocrit, Tube, Rack, Sealer, Holder (product code GHY, Class 2, 21 CFR 864.6400). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on August 18, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GHY
- Device class
- 2
- Regulation
- 864.6400
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| India | 3 |
| Pakistan | 2 |
| Poland | 1 |
| Germany | 1 |
| China | 1 |
| Denmark | 1 |
Makers of Hematocrit, Tube, Rack, Sealer, Holder
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crown Surgical Corp. | Sialkot Punjab, Pakistan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinico Medical Sp. z o.o. | Blonie/Miekinia Dolnoslaskie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drummond Scientific Co. | Broomall, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Hemocare GMBH | Friedberg Hesse, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd. (wuxi) | Wuxi Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LW Scientific, Inc. | Lawrenceville, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mian Shahid Corp. | MUZAFFAR PUR, SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitrex Medical A/S | HERLEV Hovedstaden, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 18, 1988. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.