Cleared Traditional

ANTITHROMBIN III RIA

K780012 · Ria Diagnostics · Hematology
Jan 1978
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K780012 is an FDA 510(k) clearance for the ANTITHROMBIN III RIA, a Antigen, Antiserum, Control, Antithrombin Iii (Class II — Special Controls, product code DDQ), submitted by Ria Diagnostics (Mchenry, US). The FDA issued a Cleared decision on January 20, 1978, 17 days after receiving the submission on January 3, 1978. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K780012 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1978
Decision Date January 20, 1978
Days to Decision 17 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code DDQ — Antigen, Antiserum, Control, Antithrombin Iii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7060