Cleared Traditional

COAT-A-COUNT GENTAMICIN RIA KIT

K811844 · Diagnostic Products Corp. · Chemistry
Jul 1981
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K811844 is an FDA 510(k) clearance for the COAT-A-COUNT GENTAMICIN RIA KIT, a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II — Special Controls, product code DJB), submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981, 9 days after receiving the submission on July 1, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K811844 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1981
Decision Date July 10, 1981
Days to Decision 9 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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