Cleared Traditional

K001647 - BN PROSPEC SYSTEM
(FDA 510(k) Clearance)

K001647 · Dade Behring, Inc. · Immunology device

Sep 2000

Decision

119d

Days

Class 1

Risk

K001647 is an FDA 510(k) clearance for the BN PROSPEC SYSTEM. This device is classified as a Nephelometer (Class I - General Controls, product code JZW).

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on September 26, 2000, 119 days after receiving the submission on May 30, 2000.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4540.

Submission Details

510(k) Number	K001647 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 30, 2000
Decision Date	September 26, 2000
Days to Decision	119 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF