LRH · Class I · 21 CFR 866.2660

FDA Product Code LRH: Instrument For Auto Reader Of Overnight Microorganism Identification System

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Alamar Biosciences Laboratory, Inc. and Dade Microscan, Inc..

4
Total
4
Cleared
195d
Avg days
1992
Since

FDA 510(k) Cleared Instrument For Auto Reader Of Overnight Microorganism Identification System Devices (Product Code LRH)

4 devices
1–4 of 4
Cleared Aug 30, 1996
GRAM NEGATIVE IDENTIFICATION PLUS CARD
K962609
Biomerieux Vitek, Inc.
Microbiology · 58d
Cleared May 30, 1996
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
K961042
Dade Microscan, Inc.
Microbiology · 77d
Cleared May 17, 1994
READER
K926248
Alamar Biosciences Laboratory, Inc.
Microbiology · 519d
Cleared May 22, 1992
AUTOSCEPTOR IDENTIFICATION SYSTEM
K920225
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 126d

About Product Code LRH - Regulatory Context