510(k) K860153 ยท JTN Susceptibility Test Discs, Antimicrobial
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
| Applicant | Oxoid U.S.A., Inc., Hampshire Rg 24 Op, GB |
| Decision | Substantially Equivalent, Mar 4, 1986 |
| Received | Jan 15, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860153
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2015 | Remel Inc Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge.
Used in the semi-quantitative agar diffusion test method for Terminated |
JTN | None listed |
| Mar 20, 2014 | Remel Inc Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England.
Used in the semi-quantitative agar diffu Terminated |
JTN | None listed |
| Jan 21, 2014 | Remel Inc Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, Eng Terminated |
JTN | None listed |
| Dec 17, 2013 | Remel Inc Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK.
Used in t Terminated |
JTN | None listed |
| Aug 26, 2013 | Remel Inc Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hamps Terminated |
JTN | None listed |
| Feb 12, 2013 | Remel Inc Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Ha Terminated |
JTN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.