LRR

15 FDA 510(k) clearances · Product code

FDA profile

Official device name

First Aid Kit With Drug

Device class

Not classified

Medical specialty

Unknown

FDA definition

Note: In addition to compliance with our convenience kit guidance, in regards to any drug products contained in this kit compliance with the Center for Drug Evaluation is required as well. www.fda.gov/cder/index.html - 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.

Adverse events (MAUDE)

1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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