OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS— 510(k) K860153
Substantially EquivalentOxoid U.S.A., Inc.
FDA 510(k) clearance K860153 for OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS, Substantially Equivalent on 1986-03-04. Applicant: Oxoid U.S.A., Inc.. Device class: 2.
Clearance details
- Applicant
- Oxoid U.S.A., Inc.
- Product code
- Code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hampshire Rg 24 Op, GB
Recent devices under product code JTN
view allMore clearances from Oxoid U.S.A., Inc.
view allRecalls naming K860153
K-number listed on FDA's recall record- Z-0443-2016 — 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 in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
- Z-1246-2014 — 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 diffusion test method for in-vitro susceptibility testing.
- Z-0794-2014 — 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, England. Used in the semi-quantitative agar diffusion test method for in- vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes
- Z-2081-2013 — 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, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
- Z-0528-2014 — 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 the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
- Z-0808-2013 — 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, Hants, UK.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K860153.
Data sourced from openFDA. This site is unofficial and independent of the FDA.