510(k) K983599

SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT by Andwin Scientific — Product Code HHT

K983599 is an FDA 510(k) premarket notification submitted by Andwin Scientific for the device "SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on December 11, 1998. The device falls under product code HHT (Spatula, Cervical, Cytological), a Class II device regulated under 21 CFR 884.4530. Andwin Scientific has at least 2 other 510(k) clearances on record.