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510(k) K972359

REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN by Remel, L.P. — Product Code JSO

K972359 is an FDA 510(k) premarket notification submitted by Remel, L.P. for the device "REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN". The FDA issued a decision of Substantially Equivalent on August 28, 1997. 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. Remel, L.P. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1997
Date Received
June 25, 1997
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 Remel, L.P.

  • K964315 — REMEL STAPH LATEX KIT (February 7, 1997)
  • K964421 — REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK (December 6, 1996)
  • K961046 — 10B ARGININE BROTH (September 18, 1996)
  • K955143 — RPR LIQUID CONTROLS (July 30, 1996)
  • K955136 — RPR CARD TEST KIT (July 29, 1996)
  • K961818 — GENTAMICIN DISK (120MCG) (July 10, 1996)
  • K961819 — STREPTOMYCIN DISK (300MCG) (July 10, 1996)
  • K960313 — MUELLER HINTON AGAR WITH 2% NACI (March 25, 1996)
  • K954986 — GC BASE W/ 1% GCHI (February 16, 1996)

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)
  • K162076 — chromID MRSA (October 25, 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)

FDA data resources