510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780889Substantially Equivalent

Digoxin Standards in Human Serum

Pcl-Ria, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780889 is the FDA 510(k) clearance record for DIGOXIN STANDARDS IN HUMAN SERUM, a class I device, cleared for Pcl-Ria, Inc. on under FDA product code DMP (Digoxin Control Serum, Ria). FDA records list 29 510(k) clearances for Pcl-Ria, Inc., from to . As of , FDA records show no recalls naming K780889.

Clearance record

Decision date
Received
(75 days to decision)
Product code
DMP Digoxin Control Serum, Ria
Regulation
21 CFR 862.3280
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Pcl-Ria, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DMP

Trailing 12 months

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

FDA records show no clearances under product code DMP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DMP, 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