SYNERGY SCREEN TEST, MODIFICATION— 510(k) K921977

Name: FDA 510(k) clearance K921977
Creator: U.S. Food and Drug Administration
Published: 1993-10-12

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K921977 for SYNERGY SCREEN TEST, MODIFICATION, Substantially Equivalent on 1993-10-12. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code LRG
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1992-04-21
Decision date: 1993-10-12
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 Healthcare Corp

view all

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