RIM-UREA— 510(k) K843571

Substantially Equivalent

Austin Biological Laboratories

FDA 510(k) clearance K843571 for RIM-UREA, Substantially Equivalent on 1984-10-01. Applicant: Austin Biological Laboratories. Device class: 1.

Clearance details

Applicant: Austin Biological Laboratories
Product code: Code JSS
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1984-09-11
Decision date: 1984-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSS

K150031 — hemoFISH Masterpanel2015-10-01
K123418 — GRAM-NEGATIVE QUICKFISH BC2013-07-21
K101558 — GNR TRAFFIC LIGHT PNA FISH2010-12-16
K092236 — E.COLI/P. AERUGINOSA PNA FISH2009-12-16
K092393 — EK/P. AERUGINOSA PNA FISH2009-09-01

More clearances from Austin Biological Laboratories

K880511 — XACT NEISSERIA1988-08-25
K874727 — PRECEPT(TM) CIPROFLOXACIN1988-02-18
K870769 — AUSTIN NONFERMENTER KIT1987-04-03
K864069 — PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID1986-11-13
K862446 — PRECEPT CEFTAZIDIME1986-07-11

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