Cleared Traditional

RESOLVE-CSF

K843122 · Isolab, Inc. · Chemistry
Nov 1984
Decision
114d
Days
Class 1
Risk

About This 510(k) Submission

K843122 is an FDA 510(k) clearance for the RESOLVE-CSF, a Total Spinal-fluid, Antigen, Antiserum, Control (Class I — General Controls, product code DFI), submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on November 30, 1984, 114 days after receiving the submission on August 8, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5860.

Submission Details

510(k) Number K843122 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1984
Decision Date November 30, 1984
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DFI — Total Spinal-fluid, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5860