510(k) K083117 ยท LKO Anti-Rnp Antibody, Antigen And Control
ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, May 28, 2009 |
| Received | Oct 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083117
No recall in the FDA data names this 510(k).
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