510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071146Substantially Equivalent

Vidas B.r.a.h.m.s. Pct Assay

bioMerieux, Inc., Hazelwood MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071146 is the FDA 510(k) clearance record for VIDAS B.R.A.H.M.S. PCT ASSAY, a class II device, cleared for bioMerieux, Inc. on under FDA product code NTM (Antigen, Inflammatory Response Marker, Sepsis). FDA's definition for product code NTM reads: "An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma". FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show one recall naming K071146.

Clearance record

Decision date
Received
(170 days to decision)
Product code
NTM Antigen, Inflammatory Response Marker, Sepsis
Regulation
21 CFR 866.3210
Device class
Class II
Review panel
Microbiology
Applicant
bioMerieux, Inc. 595 Anglum Rd., Hazelwood MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTM

Trailing 12 months

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

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