Pacific Andrology, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Pacific Andrology, Inc. makes
Pacific Andrology, Inc. manufactures laboratory consumables for assisted reproductive technology, including media formulations like PURECEPTION (lower and upper phase) with additives such as HEPES-buffered Ham’s F-10 and human serum albumin (HSA). The company also produces specialized micropipettes for embryo manipulation, such as assisted hatching, denuding, holding, intracytoplasmic sperm injection (ICSI), and partial zona dissection tools.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Pureception Lower Phase, Pureception Upper Phase, Pureception With Hepes-Buffered Ham's F-10 And Hsa Ref K991381
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pacific Andrology, Inc. have in the registry?
The registry currently lists 2 devices for Pacific Andrology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pacific Andrology, Inc.'s devices?
Among its 2 most recently registered devices, Pacific Andrology, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Pacific Andrology, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pacific Andrology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pacific Andrology, Inc. in the registry?
The most recently registered devices listed for Pacific Andrology, Inc. include PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA and ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING MICROPIPETTES, ICSI MICROPIPETTES, PARTIAL ZONE DISSECTION M.