Cleared Traditional

COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2

K901859 · Diagnostic Products Corp. · Immunology
May 1990
Decision
9d
Days
Class 2
Risk

About This 510(k) Submission

K901859 is an FDA 510(k) clearance for the COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2, a Radioimmunoassay, Immunoglobulins (d, E) (Class II — Special Controls, product code JHR), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 3, 1990, 9 days after receiving the submission on April 24, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K901859 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1990
Decision Date May 03, 1990
Days to Decision 9 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JHR — Radioimmunoassay, Immunoglobulins (d, E)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510