Data / Medical devices / Sampler, Amniotic Fluid (Amniocentesis Tray)
Sampler, Amniotic Fluid (Amniocentesis Tray) (HIO): 18 FDA-registered makers in 9 countries
18 establishments in 9 countries are registered with the FDA to make Sampler, Amniotic Fluid (Amniocentesis Tray) (product code HIO, Class 1, 21 CFR 884.1550). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on March 14, 1996, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HIO
- Device class
- 1
- Regulation
- 884.1550
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Mexico | 2 |
| Canada | 1 |
| China | 1 |
| Malaysia | 1 |
| Honduras | 1 |
| United Kingdom | 1 |
| Japan | 1 |
| Sweden | 1 |
Makers of Sampler, Amniotic Fluid (Amniocentesis Tray)
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 |
|---|---|---|---|---|---|---|---|---|
| pro-lab incorporated | Richmond Hill Ontario, Canada | Manufacturer | 1 | September 1, 1993 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Meiguan Care Products Technology Co.,ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospitech Manufacturing Services Sdn Bhd | Shah Alam Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Wire And Equipment Co. Ltd. | Corsham, Wiltshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sklar Corporation | Malvern, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unisis Corp. | Koshigaya-shi Saitama, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vitrolife Sweden AB | Vastra Frolunda Vastra Gotaland, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 14, 1996. 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.