Cleared Traditional

A.QC HCT LEVEL 1 AND 2

K893562 · Johnson & Johnson Professionals, Inc. · Hematology
Jul 1989
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K893562 is an FDA 510(k) clearance for the A.QC HCT LEVEL 1 AND 2, a Control, Hematocrit (Class II — Special Controls, product code GLK), submitted by Johnson & Johnson Professionals, Inc. (Roseville, US). The FDA issued a Cleared decision on July 14, 1989, 66 days after receiving the submission on May 9, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K893562 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1989
Decision Date July 14, 1989
Days to Decision 66 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GLK — Control, Hematocrit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625