COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,

About This 510(k) Submission

K002385 is an FDA 510(k) clearance for the COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on September 18, 2000, 45 days after receiving the submission on August 4, 2000. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.