Bayer Rapidpoint 405 System
FDA 510(k) K020616 · Bayer Diagnostics Corp.
510(k) numberK020616
Submission
- Device name
- Bayer Rapidpoint 405 System
- Applicant
- Bayer Diagnostics Corp.
Medfield, MA, US - Received
- February 25, 2002
- Decision date
- July 17, 2002
- 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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| 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 |
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Questions and answers
When was Bayer Rapidpoint 405 System cleared by the FDA?
Bayer Rapidpoint 405 System (K020616) received a 510(k) decision of Substantially Equivalent on July 17, 2002, 142 days after the submission was received.
What is the product code of K020616?
The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.