HemoCue Hb 801 System
FDA 510(k) K181751 · Hemocue AB
510(k) numberK181751
Submission
- Device name
- HemoCue Hb 801 System
- Applicant
- Hemocue AB
Ängelholm, SE - Received
- July 2, 2018
- Decision date
- February 1, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | Hemocue AB | 08/04/2020SE |
| K200909 | Hemo Control (optional Add Pack Hemo Control DM)GKR · Special | Ekf-Diagnostic GmbH | 06/12/2020SE |
| K182298 | hemochroma PLUS SystemGKR · Traditional | Immunostics Inc., | 11/16/2018SE |
| K172173 | DiaSpect Tm, DiaSpect Tm CuvettesGKR · Traditional | Ekf-Diagnostic GmbH | 04/06/2018SE |
| K163465 | hemochroma PLUS SystemGKR · Traditional | Immunostics Inc., | 09/08/2017SE |
| K122553 | Mission Plus HB Hemoglobin Testing SystemGKR · Traditional | ACON Laboratories, Inc. | 08/05/2013SE |
| K121752 | Avie Total HB Test SystemGKR · Traditional | Mec Dynamics Corp | 01/07/2013SE |
| K110393 | Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin…GKR · Special | Ekf-Diagnostic GmbH | 03/04/2011SE |
| K090093 | Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement SystemGKR · Special | Stanbio Laboratory | 06/10/2009SE |
| K081719 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemGKR · Special | Stanbio Laboratory | 07/18/2008SE |
More from Stanbio Laboratory
| 510(k) | Device | Decision |
|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | 08/04/2020SE |
| K071652 | Hemocue WBC SystemGKL · Traditional | 10/25/2007SE |
| K060765 | Hemocue Glucose 201 RT Analyzer MDL 120731, Hemocue Glucose 201 RT Microcurettes MDL…LFR · Traditional | 09/06/2006SE |
| K061047 | Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801GKR · Traditional | 06/08/2006SE |
| K053253 | Hemocue Albumin 201 Analyzing SystemKQO · Traditional | 02/17/2006SE |
| K041234 | Hemocue Hemoglobin 201DM Analyzing SystemGKR · Special | 06/10/2004SE |
| K041230 | Clinical Laboratory Analyzing SystemLFR · Special | 05/20/2004SE |
| K032203 | Hemocue Hemoglobin 201 + System Article 121704GKR · Special | 08/25/2003SE |
| K020935 | Hemocue Glucose 201 System, Article Number 120706CGA · Special | 04/03/2002SE |
| K962415 | Hemocue B-Glcose SystemLFR · Traditional | 10/15/1996SE |
Questions and answers
When was HemoCue Hb 801 System cleared by the FDA?
HemoCue Hb 801 System (K181751) received a 510(k) decision of Substantially Equivalent on February 1, 2019, 214 days after the submission was received.
What is the product code of K181751?
The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.