510(k) K952220

MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT by Meretek Diagnostics, Inc. — Product Code LYR

K952220 is an FDA 510(k) premarket notification submitted by Meretek Diagnostics, Inc. for the device "MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on September 17, 1996. The device falls under product code LYR (Helicobacter Pylori), a Class I device regulated under 21 CFR 866.3110. Meretek Diagnostics, Inc. has at least 2 other 510(k) clearances on record.