Data / Medical devices / Labware, Assisted Reproduction / United States
FDA-registered makers of Labware, Assisted Reproduction in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Labware, Assisted Reproduction (product code MQK). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Labware, Assisted Reproduction
- Product code
- MQK
- Country
- United States
Makers of Labware, Assisted Reproduction in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 5 | March 8, 2018 | 0 | 4 | 0 | api.fda.gov |
| LifeGlobal Group, LLC | Trumbull, CT, United States | Specification developer | 2 | August 13, 2008 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer | 1 | June 4, 2021 | 0 | 0 | 0 | api.fda.gov |
| Biotech, Inc. | Alpharetta, GA, United States | Manufacturer, Specification developer | 1 | January 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | March 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Irvine Scientific LLC | Santa Ana, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | September 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Natech Plastics | Ronkonkoma, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.