510(k) K991074 ยท MJH Legionella, Spp., Elisa
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
| Applicant | Intracel Corp., Rockville MD, US |
| Decision | Substantially Equivalent, Dec 21, 1999 |
| Received | Mar 31, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991074
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2025 | Trinity Biotech USA Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440.
In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease. Open, Classified |
MJH | None listed |
| Oct 11, 2021 | Clark Laboratories, Inc. Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or current Legionnaire's Disease by qualitative detection of Legionella Pneumophila seragroup 1 antigen Terminated |
MJH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.