Mid-Atlantic Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Mid-Atlantic Diagnostics, Inc. makes
Mid-Atlantic Diagnostics, Inc. manufactures laboratory tools for assisted reproductive technology, including devices for embryo handling such as THE STRIPPER and THE STRIPPER PGD, as well as cryopreservation tools like the CRYOPETTE. The company also produces custom IVF workstations in configurations like WKST-24*36, WKST-24*48, and their accessories, designed for controlled processing environments.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company operates within the United States, where its products are listed for use in clinical and laboratory settings.
Catalogue
The Stripper Ref K993699
Regimes: 510(k) Registry: 510(k)Cryopette Ref K100596
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
The Stripper Pgd Ref K041435
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mid-Atlantic Diagnostics, Inc. have in the registry?
The registry currently lists 4 devices for Mid-Atlantic Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mid-Atlantic Diagnostics, Inc.'s devices?
Among its 4 most recently registered devices, Mid-Atlantic Diagnostics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Mid-Atlantic Diagnostics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Mid-Atlantic Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mid-Atlantic Diagnostics, Inc. in the registry?
The most recently registered devices listed for Mid-Atlantic Diagnostics, Inc. include THE STRIPPER, CRYOPETTE, CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES and THE STRIPPER PGD.