510(k) K050328 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
PREGNANCY-SKREEN
| Applicant | Biochemical Diagnostic, Inc., Edgewood NY, US |
| Decision | Substantially Equivalent, Mar 29, 2005 |
| Received | Feb 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050328
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2024 | Mckesson Medical-Surgical Inc. Corporate Office Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL Open, Classified |
JJX | None listed |
| Nov 23, 2015 | Biochemical Diagnostics Inc CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD
Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures a Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.