FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (K250117)
Description
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette by Assure Tech., LLC, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250117
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (K250117) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, ... | Assure Tech. Co., Ltd. | 2016 |
Trace the full predicate network for K250117
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.