HAEMOPHILUS TEST MEDIUM (BROTH)— 510(k) K894848

Name: FDA 510(k) clearance K894848
Creator: U.S. Food and Drug Administration
Published: 1989-09-06

Substantially Equivalent

Regional Media Laboratories

FDA 510(k) clearance K894848 for HAEMOPHILUS TEST MEDIUM (BROTH), Substantially Equivalent on 1989-09-06. Applicant: Regional Media Laboratories. Device class: 2.

Clearance details

Applicant: Regional Media Laboratories
Product code: Code JSO
Device class: Class 2
Regulation: 21 CFR 866.1700
Advisory panel: Microbiology
Date received: 1989-07-31
Decision date: 1989-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSO

view all

K190553 — HardyCHROM CRE2019-04-29
K181092 — CHROMID CARBA agar (CARB)2018-07-06
K171061 — MRSASelect II2017-12-28
K162620 — Remel Spectra ESBL2017-05-01
K160512 — HardyCHROM ESBL2016-11-15

More clearances from Regional Media Laboratories

view all

K792674 — CAMPY BLOOD AGAR1980-01-28

Adverse events under product code JSO

product code JSO

Malfunction: 602
Total: 602

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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