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510(k) K072827

RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE by Remel, Inc. — Product Code MJE

K072827 is an FDA 510(k) premarket notification submitted by Remel, Inc. for the device "RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE". The FDA issued a decision of Substantially Equivalent on November 26, 2007. The device falls under product code MJE (Culture Media, Antifungal, Susceptibility Test), a Class II device regulated under 21 CFR 866.1700. Remel, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2007
Date Received
October 3, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antifungal, Susceptibility Test
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type

Other clearances by Remel, Inc.

  • K162620 — Remel Spectra ESBL (May 1, 2017)
  • K131804 — REMEL XPECT FLU A&B (July 12, 2013)
  • K092407 — REMEL SPECTRA MRSA (October 8, 2010)
  • K041951 — XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B (November 15, 2004)
  • K033479 — PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (February 26, 2004)
  • K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (November 18, 2003)
  • K031965 — XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (November 14, 2003)
  • K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (November 10, 2003)
  • K031565 — XPECT INFLUENZA A/B (July 17, 2003)
  • K013711 — BACTI-SWAB DRY (November 26, 2001)

FDA data resources