Cleared Traditional

ROENTGENOGRAPHY SET

K830229 · Mallinckrodt Critical Care · Immunology
Mar 1983
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K830229 is an FDA 510(k) clearance for the ROENTGENOGRAPHY SET, a Igg, Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DGD), submitted by Mallinckrodt Critical Care (Walker, US). The FDA issued a Cleared decision on March 9, 1983, 44 days after receiving the submission on January 24, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K830229 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1983
Decision Date March 09, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DGD — Igg, Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510