510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905719Substantially Equivalent

Eclipse Ica Digoxin

Biotope, Inc., Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905719 is the FDA 510(k) clearance record for ECLIPSE ICA DIGOXIN, a class II device, cleared for Biotope, Inc. on under FDA product code DPO (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.). FDA records list 7 510(k) clearances for Biotope, Inc., from to . As of , FDA records show no recalls naming K905719.

Clearance record

Decision date
Received
(27 days 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
Biotope, Inc. 12277 134th Ct., NE, Redmond WA
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