510(k) K152768 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
| Applicant | Assure Tech. Co., Ltd., Hangzhou, CN |
| Decision | Substantially Equivalent, Feb 24, 2016 |
| Received | Sep 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152768
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.