510(k) K030525

CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES by Mid-Atlantic Diagnostics, Inc. — Product Code MQG

K030525 is an FDA 510(k) premarket notification submitted by Mid-Atlantic Diagnostics, Inc. for the device "CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60, WKST-24*72 AND WKST-24*72D PLUS ACCESSORIES". The FDA issued a decision of Substantially Equivalent on August 27, 2003. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Mid-Atlantic Diagnostics, Inc. has at least 3 other 510(k) clearances on record.