510(k) K884940

RELLPLATE C KIT, RELLPLATE C BULK PLATES by American Diagnostic Corp. — Product Code GGP

K884940 is an FDA 510(k) premarket notification submitted by American Diagnostic Corp. for the device "RELLPLATE C KIT, RELLPLATE C BULK PLATES". The FDA issued a decision of Substantially Equivalent on March 13, 1989. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. American Diagnostic Corp. has at least 10 other 510(k) clearances on record.