Cleared Traditional

AMES TDA SISOMICIN TEST-CONTROL SERUM

K832792 · Miles Laboratories, Inc. · Chemistry
Sep 1983
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K832792 is an FDA 510(k) clearance for the AMES TDA SISOMICIN TEST-CONTROL SERUM, a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II — Special Controls, product code DJB), submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983, 44 days after receiving the submission on August 16, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K832792 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 1983
Decision Date September 29, 1983
Days to Decision 44 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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