510(k) K771442

MULTISTAT III UREA NITROGEN TEST by Instrumentation Laboratory CO — Product Code CDN

K771442 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "MULTISTAT III UREA NITROGEN TEST". The FDA issued a decision of Substantially Equivalent on August 22, 1977. The device falls under product code CDN (Urease, Photometric, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.