Cleared Traditional

K800180 - VARIOUS REAGENTS FOR BLOOD CELL ANALYZER
(FDA 510(k) Clearance)

K800180 · Laboratory Products, Inc. · Hematology

Mar 1980

Decision

50d

Days

Class 1

Risk

K800180 is an FDA 510(k) clearance for the VARIOUS REAGENTS FOR BLOOD CELL ANALYZER, a Diluent, Blood Cell (Class I — General Controls, product code GIF), submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1980, 50 days after receiving the submission on January 29, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8200.

Submission Details

510(k) Number	K800180 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 1980
Decision Date	March 19, 1980
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—