510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851032Substantially Equivalent

Cobas Fp Reagents for Digoxin & Cobas Fp Digoxin C

Roche Diagnostic Systems, Inc., Belleville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851032 is the FDA 510(k) clearance record for COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code KXT (Enzyme Immunoassay, Digoxin). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show one recall naming K851032.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KXT Enzyme Immunoassay, Digoxin
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Roche Diagnostic Systems, Inc. 11 Franklin Ave., Belleville NJ
Third party review
No

Clearances, product code KXT

Trailing 12 months

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

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