510(k) K943008 ยท JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
BIOSCAN REAGENT STRIPS
| Applicant | Genesis Labs, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Aug 8, 1994 |
| Received | Jun 24, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943008
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.