510(k) K042307

ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) by Seradyn, Inc. — Product Code JIT

K042307 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)". The FDA issued a decision of Substantially Equivalent on November 3, 2004. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Seradyn, Inc. has at least 10 other 510(k) clearances on record.