510(k) K964491 ยท JTN Susceptibility Test Discs, Antimicrobial
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
| Applicant | Unipath , Ltd., Beverly MA, US |
| Decision | Substantially Equivalent, Feb 7, 1997 |
| Received | Nov 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964491
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2014 | Remel Inc Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, En Terminated |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.