510(k) K791385

NEGATIVE CONTROL SERUM FOR CF RO ID by Immuno-Mycologics, Inc. — Product Code GSN

K791385 is an FDA 510(k) premarket notification submitted by Immuno-Mycologics, Inc. for the device "NEGATIVE CONTROL SERUM FOR CF RO ID". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code GSN (Antiserum, Positive And Negative Febrile Antigen Control Serum), a Class II device regulated under 21 CFR 866.3085. Immuno-Mycologics, Inc. has at least 10 other 510(k) clearances on record.