510(k) K770411

DIGI TROL TM-RX & DIGI TROL TM-TX by Nuclear Medical Laboratories, Inc. — Product Code DMP

K770411 is an FDA 510(k) premarket notification submitted by Nuclear Medical Laboratories, Inc. for the device "DIGI TROL TM-RX & DIGI TROL TM-TX". The FDA issued a decision of Substantially Equivalent on March 16, 1977. The device falls under product code DMP (Digoxin Control Serum, Ria), a Class I device regulated under 21 CFR 862.3280. Nuclear Medical Laboratories, Inc. has at least 10 other 510(k) clearances on record.