VIDAS B.R.A.H.M.S. PCT ASSAY— 510(k) K071146

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K071146 for VIDAS B.R.A.H.M.S. PCT ASSAY, Substantially Equivalent on 2007-10-11. Applicant: bioMerieux, Inc.. Device class: 2.

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code NTM
Device class: Class 2
Regulation: 21 CFR 866.3210
Advisory panel: Microbiology
Date received: 2007-04-24
Decision date: 2007-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K071146

K-number listed on FDA's recall record

Z-0868-2023 — VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01Class II·Ongoing·Biomerieux Inc·20221109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071146.

Data sourced from openFDA. This site is unofficial and independent of the FDA.