Cleared Traditional

K800003 - CORTEX DOUBLE HELIX SAMPLER
(FDA 510(k) Clearance)

K800003 · Cortex Research Corp. · Hematology device

Feb 1980

Decision

30d

Days

Class 1

Risk

K800003 is an FDA 510(k) clearance for the CORTEX DOUBLE HELIX SAMPLER. This device is classified as a Mixer, Blood Tube (Class I - General Controls, product code GLE).

Submitted by Cortex Research Corp. (Walker, US). The FDA issued a Cleared decision on February 1, 1980, 30 days after receiving the submission on January 2, 1980.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K800003 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 02, 1980
Decision Date	February 01, 1980
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—