Mission Plus HB Hemoglobin Testing System
FDA 510(k) K122553 · ACON Laboratories, Inc.
510(k) numberK122553
Submission
- Device name
- Mission Plus HB Hemoglobin Testing System
- Applicant
- ACON Laboratories, Inc.
San Diego, CA, US - Received
- August 21, 2012
- Decision date
- August 5, 2013
- 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
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|---|---|---|---|
| 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 |
| 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 |
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Questions and answers
When was Mission Plus HB Hemoglobin Testing System cleared by the FDA?
Mission Plus HB Hemoglobin Testing System (K122553) received a 510(k) decision of Substantially Equivalent on August 5, 2013, 349 days after the submission was received.
What is the product code of K122553?
The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.