510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K935229Substantially Equivalent

Opus Digitoxin

Pb Diagnostic Systems, Inc., Westwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935229 is the FDA 510(k) clearance record for OPUS DIGITOXIN, a class II device, cleared for Pb Diagnostic Systems, Inc. on under FDA product code DPG (Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.). FDA records list 35 510(k) clearances for Pb Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K935229.

Clearance record

Decision date
Received
(51 days to decision)
Product code
DPG Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Regulation
21 CFR 862.3300
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Pb Diagnostic Systems, Inc. 151 University Ave., Westwood MA
510(k) summary
Statement
Third party review
No

Clearances, product code DPG

Trailing 12 months

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

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