510(k) K961792

BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS by Biocircuits Corp. — Product Code DHA

K961792 is an FDA 510(k) premarket notification submitted by Biocircuits Corp. for the device "BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS". The FDA issued a decision of Substantially Equivalent on August 21, 1996. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Biocircuits Corp. has at least 7 other 510(k) clearances on record.