Cleared Traditional

K920207 - HERMLE Z230H
(FDA 510(k) Clearance)

K920207 · Labnet Intl., Inc. · Hematology

Jun 1992

Decision

145d

Days

Class 2

Risk

K920207 is an FDA 510(k) clearance for the HERMLE Z230H, a Centrifuge, Hematocrit (Class II — Special Controls, product code GKG), submitted by Labnet Intl., Inc. (Woodbridge, US). The FDA issued a Cleared decision on June 9, 1992, 145 days after receiving the submission on January 16, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number	K920207 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 1992
Decision Date	June 09, 1992
Days to Decision	145 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement