510(k) K791354

CODE QAS 103 ANTI-DNA CONTROLS by Amersham Corp. — Product Code KTL

K791354 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "CODE QAS 103 ANTI-DNA CONTROLS". The FDA issued a decision of Substantially Equivalent on September 17, 1979. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Amersham Corp. has at least 10 other 510(k) clearances on record.