510(k) K163042

chromID Strepto B agar by bioMerieux, Inc. — Product Code PQZ

K163042 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "chromID Strepto B agar". The FDA issued a decision of Substantially Equivalent on January 27, 2017. The device falls under product code PQZ (Gbs Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 27, 2017
Date Received: October 31, 2016
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Gbs Culture Media, Selective And Differential
Device Class: Class I
Regulation Number: 866.2360
Review Panel: MI
Submission Type

Culture Medium for GBS Detection

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K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (April 30, 2025)
K234012 — VITEK COMPACT PRO (March 14, 2025)
K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) (June 12, 2024)
K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (June 7, 2024)
K240279 — VIDAS TBI (GFAP, UCH-L1) (May 1, 2024)
K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)

510(k) K163042

Clearance Details

Device Classification

Other clearances by bioMerieux, Inc.

Other clearances for product code PQZ

FDA data resources