Laser-Globin
FDA 510(k) K850096 · Hematology Marketing Assoc.
510(k) numberK850096
Submission
- Device name
- Laser-Globin
- Applicant
- Hematology Marketing Assoc.
Concord, CA, US - Received
- January 11, 1985
- Decision date
- March 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K851843 | Osmocel 3GIF · Traditional | 07/30/1985SE |
| K851375 | Tri-CountJPK · Traditional | 07/12/1985SE |
| K850097 | Laser-LyseGGK · Traditional | 03/29/1985SE |
| K850095 | Laser-DilGIF · Traditional | 03/29/1985SE |
| K850094 | Laser-Globin PowderGKR · Traditional | 03/29/1985SE |
| K844708 | Tri-Count CalibratorKSA · Traditional | 03/05/1985SE |
| K843485 | Tri-Count LaserJPK · Traditional | 12/12/1984SE |
| K834371 | Tri-Count 10JPK · Traditional | 03/09/1984SE |
| K833130 | Tri-Count 7JPK · Traditional | 10/20/1983SE |
| K831306 | HemacalKRZ · Traditional | 06/16/1983SE |
Questions and answers
When was Laser-Globin cleared by the FDA?
Laser-Globin (K850096) received a 510(k) decision of Substantially Equivalent on March 29, 1985, 77 days after the submission was received.
What is the product code of K850096?
The FDA product code is GKR – System, Hemoglobin, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5620.