Cleared Traditional

K873401 - TURBOX
(FDA 510(k) Clearance)

K873401 · Unipath , Ltd. · Hematology device

Sep 1987

Decision

30d

Days

Class 1

Risk

K873401 is an FDA 510(k) clearance for the TURBOX. This device is classified as a Nephelometer (Class I - General Controls, product code JZW).

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on September 23, 1987, 30 days after receiving the submission on August 24, 1987.

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

Submission Details

510(k) Number	K873401 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 24, 1987
Decision Date	September 23, 1987
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—