MUELLER HINTON AGAR— 510(k) K132491

Substantially Equivalent

Edge Biologicals, Inc.

FDA 510(k) clearance K132491 for MUELLER HINTON AGAR, Substantially Equivalent on 2014-06-30. Applicant: Edge Biologicals, Inc.. Device class: 2.

Clearance details

Applicant: Edge Biologicals, Inc.
Product code: Code JTZ
Device class: Class 2
Regulation: 21 CFR 866.1700
Advisory panel: Microbiology
Date received: 2013-08-08
Decision date: 2014-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTZ

K963036 — MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD1996-10-07
K960420 — MUELLER HINTON AGAR WITH 5% SHEEP BLOOD1996-04-04
K960313 — MUELLER HINTON AGAR WITH 2% NACI1996-03-25
K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS1995-04-04
K941985 — MUELLER HINTON AGAR W/OXACILLIN1994-08-24

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