MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL— 510(k) K922482

Name: FDA 510(k) clearance K922482
Creator: U.S. Food and Drug Administration
Published: 1993-03-12

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K922482 for MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL, Substantially Equivalent on 1993-03-12. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code LRG
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1992-05-27
Decision date: 1993-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRG

view all

K191914 — Thermo Scientific Sensititre ARIS HiQ System2019-11-06
K191918 — Thermo Scientific Sensititre ARIS HiQ System2019-11-06
K110583 — SENSITITRE OPTIREAD2011-09-22
K103532 — AUTOREADER 22011-08-26
K111677 — MICROSCAN(R) MICROSTREP PLUS(R)2011-08-04

More clearances from Baxter Diagnostics, Inc.

view all

K934458 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1995-07-18
K950817 — DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI1995-04-25
K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS1995-04-14
K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY1995-04-11
K945235 — DRIED GRAM-POSITIVE MIC/COMBO PANELS1995-03-07

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