REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN— 510(k) K972359
Substantially EquivalentRemel, L.P.
FDA 510(k) clearance K972359 for REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN, Substantially Equivalent on 1997-08-28. Applicant: Remel, L.P.. Device class: 2.
Clearance details
- Applicant
- Remel, L.P.
- Product code
- Code JSO
- Device class
- Class 2
- Regulation
- 21 CFR 866.1700
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lenexa, KS, US
Recent devices under product code JSO
view allMore clearances from Remel, L.P.
view allAdverse events under product code JSO
product code JSO- Malfunction
- 602
- Total
- 602
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K972359
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972359.
Data sourced from openFDA. This site is unofficial and independent of the FDA.