Cleared Traditional

IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN

K831961 · Kent Laboratories, Inc. · Chemistry
Aug 1983
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K831961 is an FDA 510(k) clearance for the IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983, 55 days after receiving the submission on June 17, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K831961 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1983
Decision Date August 11, 1983
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JBQ — Antithrombin Iii Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7060

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