Cleared Traditional

K842834 - HEP-2 CELLS (FDA 510(k) Clearance)

K842834 · Bartels Immunodiagnostic Supplies, Inc. · Immunology device
Aug 1984
Decision
39d
Days
Class 1
Risk

K842834 is an FDA 510(k) clearance for the HEP-2 CELLS. This device is classified as a Erythrosin B (Class I - General Controls, product code KJR).

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984, 39 days after receiving the submission on July 20, 1984.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K842834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date August 28, 1984
Days to Decision 39 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code KJR — Erythrosin B
Device Class Class I - General Controls
CFR Regulation 21 CFR 864.1850