Cleared Traditional

AMES TDA GENTAMICIN TEST

K821669 · Miles Laboratories, Inc. · Chemistry
Dec 1982
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K821669 is an FDA 510(k) clearance for the AMES TDA GENTAMICIN TEST, a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II — Special Controls, product code DJB), submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on December 15, 1982, 191 days after receiving the submission on June 7, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K821669 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 1982
Decision Date December 15, 1982
Days to Decision 191 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DJB — Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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