Product code LRR— Unknown

AUTO FIRST-AID KIT FOR AMERICA

Classification name
First Aid Kit With Drug
Device class
Not classified
Advisory panel
Unknown
Total cleared
15
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code LRR, via openFDA

Market context for product code LRR

FDA has cleared 15 devices under product code LRR between 1984 and 1997, filed by 12 applicant companies. No FDA device recalls reference this product code.

Clearances per year

Top applicants under product code LRR

Recent clearances under product code LRR

Data sourced from openFDA. This site is unofficial and independent of the FDA.