MUELLER HINTON AGAR— 510(k) K802498

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K802498 for MUELLER HINTON AGAR, Substantially Equivalent on 1980-11-12. Applicant: Oxoid U.S.A., Inc.. Device class: 2.

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code JTZ
Device class: Class 2
Regulation: 21 CFR 866.1700
Advisory panel: Microbiology
Date received: 1980-10-10
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTZ

K132491 — MUELLER HINTON AGAR2014-06-30
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

More clearances from Oxoid U.S.A., Inc.

K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM1989-06-09
K884026 — ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT1989-02-03
K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)1988-10-25
K874303 — STAPHYLASE TEST1987-11-06
K872956 — SORBITOL MACCONKEY AGAR NO. 3 CM 8131987-08-10

Recalls naming K802498

K-number listed on FDA's recall record

Z-0209-2018 — CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.Class II·Terminated·Remel Inc·20171102

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K802498.

Data sourced from openFDA. This site is unofficial and independent of the FDA.