DiaSpect Tm, DiaSpect Tm Cuvettes
FDA 510(k) K172173 · Ekf-Diagnostic GmbH
510(k) numberK172173
Submission
- Device name
- DiaSpect Tm, DiaSpect Tm Cuvettes
- Applicant
- Ekf-Diagnostic GmbH
Barleben, DE - Received
- July 19, 2017
- Decision date
- April 6, 2018
- 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 |
| 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 |
|---|---|---|
| K200909 | Hemo Control (optional Add Pack Hemo Control DM)GKR · Special | 06/12/2020SE |
| K180509 | Quo-Test A1c SystemLCP · Dual Track | 02/16/2019SE |
| K110393 | Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin…GKR · Special | 03/04/2011SE |
| K031898 | Ekf Diagnostic Hemo Control Hemoglobin Measurement SystemGKR · Traditional | 09/24/2003SE |
Questions and answers
When was DiaSpect Tm, DiaSpect Tm Cuvettes cleared by the FDA?
DiaSpect Tm, DiaSpect Tm Cuvettes (K172173) received a 510(k) decision of Substantially Equivalent on April 6, 2018, 261 days after the submission was received.
What is the product code of K172173?
The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.