510(k) K152679

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak by Bio-Rad Laboratories — Product Code PMN

K152679 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories for the device "Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak". The FDA issued a decision of Substantially Equivalent on May 10, 2016. The device falls under product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays), a Class II device regulated under 21 CFR 866.3920. Bio-Rad Laboratories has at least 10 other 510(k) clearances on record.