Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801
FDA 510(k) K061047 · Hemocue AB
510(k) numberK061047
Submission
- Device name
- Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801
- Applicant
- Hemocue AB
Lake Forest, CA, US - Received
- April 14, 2006
- Decision date
- June 8, 2006
- 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 |
| K181751 | HemoCue Hb 801 SystemGKR · Traditional | Hemocue AB | 02/01/2019SE |
| 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 |
More from Stanbio Laboratory
| 510(k) | Device | Decision |
|---|---|---|
| K201217 | HemoCue Hb 301 SystemGKR · Traditional | 08/04/2020SE |
| K181751 | HemoCue Hb 801 SystemGKR · Traditional | 02/01/2019SE |
| 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 |
| 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 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 cleared by the FDA?
Hemocue HB 301 Analyzer, Model 121804 and Microcuvettes, Model 111801 (K061047) received a 510(k) decision of Substantially Equivalent on June 8, 2006, 55 days after the submission was received.
What is the product code of K061047?
The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.