510(k) K882105

CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM by Dianon Systems, Inc. — Product Code GAA

K882105 is an FDA 510(k) premarket notification submitted by Dianon Systems, Inc. for the device "CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM". The FDA issued a decision of Substantially Equivalent (with conditions) on July 11, 1988. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Dianon Systems, Inc. has at least 1 other 510(k) clearance on record.