Cleared Traditional

K862641 - U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK)
(FDA 510(k) Clearance)

K862641 · U. S. Diagnostics, Inc. · Hematology

Aug 1986

Decision

41d

Days

Class 2

Risk

K862641 is an FDA 510(k) clearance for the U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK). This device is classified as a Whole Blood Hemoglobin Determination (Class II — Special Controls, product code KHG).

Submitted by U. S. Diagnostics, Inc. (San Luis Obispo, US). The FDA issued a Cleared decision on August 21, 1986, 41 days after receiving the submission on July 11, 1986.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number	K862641 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 1986
Decision Date	August 21, 1986
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—