510(k) K984596

VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES by Zymetx, Inc. — Product Code GNR

K984596 is an FDA 510(k) premarket notification submitted by Zymetx, Inc. for the device "VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES". The FDA issued a decision of Substantially Equivalent on March 4, 1999. The device falls under product code GNR (Antisera, Neutralization, Influenza Virus A, B, C), a Class I device regulated under 21 CFR 866.3330. Zymetx, Inc. has at least 3 other 510(k) clearances on record.