Preco, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Preco, Inc. makes
Preco, Inc. manufactures rapid diagnostic tests for pregnancy and infectious diseases, including immunochromatographic card-based assays for human chorionic gonadotropin (HCG) detection and syphilis serology. Their portfolio includes point-of-care tests for immediate results, such as the Pregnancy Rapid Card Test and syphilis screening via Toluidine Red Unheated Serum Card Test. Additional offerings include immunomigration (IM) test cards for rapid pathogen detection.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company’s products are listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance standards. Preco, Inc. is headquartered in the United States.
Catalogue
Preco Pregnancy Rapid Card Test, Hem #2028 Ref K850604
Regimes: 510(k) Registry: 510(k)Card Three Im Test Item #2035, Card One Im #2036 Ref K853144
Regimes: 510(k) Registry: 510(k)Rf Card Test Ref K853054
Regimes: 510(k) Registry: 510(k)Tolvidine Red Unheated Serum Syphillis Card Test Ref K852751
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Preco, Inc. have in the registry?
The registry currently lists 4 devices for Preco, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Preco, Inc.'s devices?
Among its 4 most recently registered devices, Preco, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Preco, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Preco, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Preco, Inc. in the registry?
The most recently registered devices listed for Preco, Inc. include PRECO PREGNANCY RAPID CARD TEST, HEM #2028, CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036, RF CARD TEST and TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST.