REMEDI HS DRUG PROFILING SYSTEM— 510(k) K941596

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K941596 for REMEDI HS DRUG PROFILING SYSTEM, Substantially Equivalent on 1995-03-27. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code DNI
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 1994-04-01
Decision date: 1995-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

Download summary PDF View on FDA.gov ↗

More clearances from Bio-Rad

K171061 — MRSASelect II2017-12-28
K122187 — VRESELECT CULTURE MEDIUM2012-11-06
K103684 — VRESELECT CULTURE MEDIUM2011-10-21
K093678 — PLATELIA ASPERGILLUS EIA MODEL 627932011-01-13
K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS2010-10-29

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