510(k) K971170 ยท LSR Reagent, Borrelia Serological Reagent
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
| Applicant | Cambridge Biotech Corp., Rockville MD, US |
| Decision | Substantially Equivalent, Feb 17, 1998 |
| Received | Mar 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971170
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.