Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5— 510(k) K160729

Name: FDA 510(k) clearance K160729
Creator: U.S. Food and Drug Administration
Published: 2016-06-13

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K160729 for Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5, Substantially Equivalent on 2016-06-13. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code PMT
Device class: Class 2
Regulation: 21 CFR 866.3215
Advisory panel: Microbiology
Date received: 2016-03-16
Decision date: 2016-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K200236 — VITROS BRAHMS PCT Reagent Pack and Calibrators2020-02-25
K181002 — Atellica IM BRAHMS Procalcitonin (PCT)2018-07-16
K160911 — VIDAS B.R.A.H.M.S. PCT (PCT)2016-06-28
DEN150009 — B.R.A.H.M.S PCT sensitive KRYPTOR2016-02-20

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Recalls naming K160729

K-number listed on FDA's recall record

Z-1311-2018 — Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).Class II·Terminated·Roche Diagnostics Corporation·20171222

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160729.

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