chromID Strepto B agar— 510(k) K163042

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K163042 for chromID Strepto B agar, Substantially Equivalent on 2017-01-27. Applicant: bioMerieux, Inc.. Device class: 1.

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code PQZ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 2016-10-31
Decision date: 2017-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K163042

K-number listed on FDA's recall record

Z-0847-2023 — PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751Class II·Ongoing·Biomerieux Inc·20221109

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163042.

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