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510(k) K162076

chromID MRSA by bioMerieux, Inc. — Product Code JSO

K162076 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "chromID MRSA". The FDA issued a decision of Substantially Equivalent on October 25, 2016. The device falls under product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar), a Class II device regulated under 21 CFR 866.1700. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2016
Date Received
July 27, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type

Other clearances by bioMerieux, Inc.

  • K260160 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System (July 8, 2026)
  • K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (April 15, 2026)
  • K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (March 26, 2026)
  • 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)

Other clearances for product code JSO

  • K190553 — HardyCHROM CRE (April 29, 2019)
  • K181092 — CHROMID CARBA agar (CARB) (July 6, 2018)
  • K171061 — MRSASelect II (December 28, 2017)
  • K162620 — Remel Spectra ESBL (May 1, 2017)
  • K160512 — HardyCHROM ESBL (November 15, 2016)
  • K151688 — chromID MRSA (March 11, 2016)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K102922 — HARDYCHROM MRSA (May 4, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)

FDA data resources