510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852291Substantially Equivalent

Tipsep Digoxin Ria

Nuclear Diagnostics, Inc., Troy MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852291 is the FDA 510(k) clearance record for TIPSEP DIGOXIN RIA, a class II device, cleared for Nuclear Diagnostics, Inc. on under FDA product code DNL (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.). FDA records list 24 510(k) clearances for Nuclear Diagnostics, Inc., from to . As of , FDA records show no recalls naming K852291.

Clearance record

Decision date
Received
(27 days to decision)
Product code
DNL Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Nuclear Diagnostics, Inc. 575 Robbins Dr., Troy MI
Third party review
No

Clearances, product code DNL

Trailing 12 months

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

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