510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061138Substantially Equivalent

Abx Pentra 400 : Crp

Horiba Abx, Montpellier, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061138 is the FDA 510(k) clearance record for ABX PENTRA 400 : CRP, a class II device, cleared for Horiba Abx on under FDA product code DCK (C-Reactive Protein, Antigen, Antiserum, And Control). FDA records list 19 510(k) clearances for Horiba Abx, from to . As of , FDA records show no recalls naming K061138.

Clearance record

Decision date
Received
(158 days to decision)
Product code
DCK C-Reactive Protein, Antigen, Antiserum, And Control
Regulation
21 CFR 866.5270
Device class
Class II
Review panel
Immunology
Applicant
Horiba Abx Parc Euromedecine, Montpellier, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DCK

Trailing 12 months

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

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