510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800205Substantially Equivalent

Ria Phase Digoxin

Boehringer Mannheim Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800205 is the FDA 510(k) clearance record for RIA PHASE DIGOXIN, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code DPO (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K800205.

Clearance record

Decision date
Received
(49 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
Boehringer Mannheim Corp. 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