510(k) K872203

CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) by Irvine Scientific — Product Code HDR

K872203 is an FDA 510(k) premarket notification submitted by Irvine Scientific for the device "CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER)". The FDA issued a decision of Substantially Equivalent on August 14, 1987. The device falls under product code HDR (Cap, Cervical), a Class II device regulated under 21 CFR 884.5250. Irvine Scientific has at least 10 other 510(k) clearances on record.