Cleared Traditional

K893984 - HGB-CAL SET/MULTIPLE
(FDA 510(k) Clearance)

K893984 · R&D Systems, Inc. · Hematology

Aug 1989

Decision

71d

Days

Class 2

Risk

K893984 is an FDA 510(k) clearance for the HGB-CAL SET/MULTIPLE, a Calibrator For Hemoglobin And Hematocrit Measurement (Class II — Special Controls, product code KRZ), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 15, 1989, 71 days after receiving the submission on June 5, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8165.

Submission Details

510(k) Number	K893984 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 05, 1989
Decision Date	August 15, 1989
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—