510(k) K864998

IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT by Boots-Celltech Diagnostics, Inc. — Product Code JSM

K864998 is an FDA 510(k) premarket notification submitted by Boots-Celltech Diagnostics, Inc. for the device "IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on April 20, 1987. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Boots-Celltech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.