Microsample Blood Collection Device
FDA 510(k) K761137 · Ortho Diagnostics, Inc.
510(k) numberK761137
Submission
- Device name
- Microsample Blood Collection Device
- Applicant
- Ortho Diagnostics, Inc.
Mchenry, IL, US - Received
- November 24, 1976
- Decision date
- February 7, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GKH – Apparatus, Automated Blood Cell Diluting
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.5240
- Specialty
- Hematology
Other 510(k)s with product code GKH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100684 | Celltracks Autoprep System MODEL:9541GKH · Traditional | Veridex, LLC | 08/26/2010SE |
| K040077 | Immunicon Celltracks Autoprep SystemGKH · Traditional | Immunicon Corp. | 03/12/2004SE |
| K022512 | Cellprep Sample Preparation System, Model 9518GKH · Traditional | Immunicon Corp. | 09/30/2002SE |
| K021150 | Coulter CellprepGKH · Traditional | Beckman Coulter, Inc. | 06/11/2002SE |
| K935953 | Coulter Multi Q PrepGKH · Traditional | Coulter Corp. | 03/11/1994SE |
| K923530 | Coulter Multi-Q-PrepGKH · Traditional | Coulter Electronics, Inc. | 10/14/1992SE |
| K904795 | Facsprep Robotic Sample Preparation SystemGKH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/31/1990SE |
| K882767 | Sysmex DD-100 Whole Blood Dilution SystemGKH · Traditional | Toa Medical Electronics USA, Inc. | 07/18/1988SE |
| K852373 | AD150, Automated Hematology DilutorGKH · Traditional | Abbott Diagnostics | 07/05/1985SE |
| K842747 | Hycel Dilutor, Various Models/MultiGKH · Traditional | R&D Systems, Inc. | 10/01/1984SE |
More from R&D Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802404 | Ortho Bovine Albumin Solution 30% ProteDCF · Traditional | 10/23/1980SE |
| K801507 | Antigen Control CellsGOL · Traditional | 08/20/1980SE |
| K800357 | Bi-Level Assayed Card. Drug Cont., I,IiLAS · Traditional | 04/16/1980SE |
| K800310 | Ortho Antisera ControlKSF · Traditional | 03/05/1980SE |
| K791791 | Ortho Antibody Enhancement SolutionKSG · Traditional | 10/11/1979SE |
| K791301 | Ortho TSH Ria KitJLW · Traditional | 09/24/1979SE |
| K790813 | Multecon Blood Gas ControlJJS · Traditional | 06/28/1979SE |
| K782166 | Slide Test for Pregnancy, Gravindex 90JHJ · Traditional | 04/04/1979SE |
| K782063 | Pregnancy, Sensidex Tube TestJHJ · Traditional | 04/04/1979SE |
| K781638 | Rubindex*Direct SystemGOK · Traditional | 12/20/1978SE |
Questions and answers
When was Microsample Blood Collection Device cleared by the FDA?
Microsample Blood Collection Device (K761137) received a 510(k) decision of Substantially Equivalent on February 7, 1977, 75 days after the submission was received.
What is the product code of K761137?
The FDA product code is GKH – Apparatus, Automated Blood Cell Diluting, a Class I (low risk) device regulated under 21 CFR 864.5240.