510(k) K820246

PREFILLED SPECIMEN CONTAINER by Sage Products, Inc. — Product Code KDT

K820246 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "PREFILLED SPECIMEN CONTAINER". The FDA issued a decision of Substantially Equivalent on February 18, 1982. The device falls under product code KDT (Container, Specimen Mailer And Storage, Sterile), a Class I device regulated under 21 CFR 864.3250. Sage Products, Inc. has at least 10 other 510(k) clearances on record.