510(k) K862044 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
DELFIA (TM) HCG KIT
| Applicant | Lkb Instruments, Inc., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Jul 11, 1986 |
| Received | May 28, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862044
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2019 | PerkinElmer Life and Analytical Sciences, Wallac, OY DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum. Open, Classified |
JHJ | None listed |
| Jan 10, 2019 | PerkinElmer Life and Analytical Sciences, Wallac, OY AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG). Open, Classified |
JHJ | None listed |
| Jan 10, 2019 | PerkinElmer Life and Analytical Sciences, Wallac, OY AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)
Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG). Open, Classified |
JHJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.