510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770365Substantially Equivalent

Radioimmunoassay Digoxin Test, in Vitro

Travenol Laboratories, S.A., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770365 is the FDA 510(k) clearance record for RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO, a class II device, cleared for Travenol Laboratories, S.A. on under FDA product code DPO (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.). FDA records list 206 510(k) clearances for Travenol Laboratories, S.A., from to . As of , FDA records show no recalls naming K770365.

Clearance record

Decision date
Received
(1 day to decision)
Product code
DPO Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Travenol Laboratories, S.A. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DPO

Trailing 12 months

FDA records hold no clearances under product code DPO in the trailing twelve months.

FDA records show no clearances under product code DPO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DPO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260