LEGIONELLA CYE AGAR BASE & BCYE SUPPL— 510(k) K831469
Substantially EquivalentOxoid U.S.A., Inc.
FDA 510(k) clearance K831469 for LEGIONELLA CYE AGAR BASE & BCYE SUPPL, Substantially Equivalent on 1983-06-08. Applicant: Oxoid U.S.A., Inc.. Device class: 1.
Clearance details
- Applicant
- Oxoid U.S.A., Inc.
- Product code
- Code JSK
- Device class
- Class 1
- Regulation
- 21 CFR 866.2450
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code JSK
view allMore clearances from Oxoid U.S.A., Inc.
view allRecalls naming K831469
K-number listed on FDA's recall record- Z-1232-2015 — Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
- Z-0578-2015 — Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
- Z-0200-2015 — Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
- Z-1112-2014 — Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K831469.
Data sourced from openFDA. This site is unofficial and independent of the FDA.