510(k) K962052 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
ORGENTEC ABTI-SS-BB(LA) ELISA
| Applicant | American Laboratory Products Co., Ltd., Windham NH, US |
| Decision | Substantially Equivalent, Nov 15, 1996 |
| Received | May 28, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962052
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.