Hemocue Photometer Technical Manual

FDA 510(k) K832020 · Aktiebolaget Leo Diagnostics

Substantially Equivalent

510(k) numberK832020

Submission

Device name
Hemocue Photometer Technical Manual
Applicant
Aktiebolaget Leo Diagnostics
Walker, MI, US
Received
June 15, 1983
Decision date
October 28, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GKR – System, Hemoglobin, Automated
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5620
Specialty
Hematology

Other 510(k)s with product code GKR

510(k)DeviceApplicantDecision
K201217HemoCue Hb 301 SystemGKR · Traditional Hemocue AB08/04/2020SE
K200909Hemo Control (optional Add Pack Hemo Control DM)GKR · Special Ekf-Diagnostic GmbH06/12/2020SE
K181751HemoCue Hb 801 SystemGKR · Traditional Hemocue AB02/01/2019SE
K182298hemochroma PLUS SystemGKR · Traditional Immunostics Inc.,11/16/2018SE
K172173DiaSpect Tm, DiaSpect Tm CuvettesGKR · Traditional Ekf-Diagnostic GmbH04/06/2018SE
K163465hemochroma PLUS SystemGKR · Traditional Immunostics Inc.,09/08/2017SE
K122553Mission Plus HB Hemoglobin Testing SystemGKR · Traditional ACON Laboratories, Inc.08/05/2013SE
K121752Avie Total HB Test SystemGKR · Traditional Mec Dynamics Corp01/07/2013SE
K110393Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin…GKR · Special Ekf-Diagnostic GmbH03/04/2011SE
K090093Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemGKR · Special Stanbio Laboratory06/10/2009SE

Questions and answers

When was Hemocue Photometer Technical Manual cleared by the FDA?

Hemocue Photometer Technical Manual (K832020) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 135 days after the submission was received.

What is the product code of K832020?

The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.