510(k) K971519

ASSERACHROM TPA TEST KIT by American Bioproducts Co. — Product Code GGP

K971519 is an FDA 510(k) premarket notification submitted by American Bioproducts Co. for the device "ASSERACHROM TPA TEST KIT". The FDA issued a decision of Substantially Equivalent on Aug 19, 1997. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. American Bioproducts Co. has 78 other 510(k) clearances on record.