QMTClass II
Prep Kit Vaccine Injection
General Hospital · 21 CFR 880.5570
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
MDR events1All time
Recalls1All time
Registered firms2Currently listed
510(k) clearances0All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Material Separation1
Trend for “Material Separation”
Recalls
1 recall events for this product code
Registered firms
2 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.