Cell-Dyn Diff. Screen Isotonic Diluent
FDA 510(k) K873347 · Abbott Diagnostics
510(k) numberK873347
Submission
- Device name
- Cell-Dyn Diff. Screen Isotonic Diluent
- Applicant
- Abbott Diagnostics
Mountain View, CA, US - Received
- August 20, 1987
- Decision date
- September 9, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GIF – Diluent, Blood Cell
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8200
- Specialty
- Hematology
Other 510(k)s with product code GIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883990 | KVM Isotonic DiluentGIF · Traditional | Kvm Technologies, Inc. | 10/12/1988SE |
| K883989 | KVM Isotonic Flush SolutionGIF · Traditional | Kvm Technologies, Inc. | 10/12/1988SE |
| K882490 | Hycel Quick-Lysing Hemoglobin ReagentGIF · Traditional | R&D Systems, Inc. | 07/25/1988SE |
| K882267 | Sysmex Quicklyser-Ii (QLS-200A)GIF · Traditional | Toa Medical Electronics USA, Inc. | 07/12/1988SE |
| K881130 | Cell-Dyn Isotonic DiluentGIF · Traditional | Abbott Diagnostics | 03/31/1988SE |
| K851843 | Osmocel 3GIF · Traditional | Hematology Marketing Assoc. | 07/30/1985SE |
| K851320 | Sdi Prepax Dilukit M.GIF · Traditional | Scientific Distributors, Inc. | 07/05/1985SE |
| K851280 | Dass PackGIF · Traditional | Dass, Inc. | 07/05/1985SE |
| K850239 | Sysmex Hematological Whole Blood Diluting Reagent-GIF · Traditional | Toa Medical Electronics USA, Inc. | 04/01/1985SE |
| K850095 | Laser-DilGIF · Traditional | Hematology Marketing Assoc. | 03/29/1985SE |
More from Hematology Marketing Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K964185 | Imx Ca 125LTK · Traditional | 11/04/1997SE |
| K972182 | Abbott Strep a ControlsMJZ · Traditional | 08/13/1997SE |
| K961439 | Abbott Cell-Dyn 4000 SystemGKZ · Traditional | 10/18/1996SE |
| K890491 | Cell-Dyn 3000 Multi-Parameter Hematology AnalyerGKZ · Traditional | 04/18/1989SE |
| K881242 | Cell-Dyn Rapid-Lyse and HemogloblinGJZ · Traditional | 04/21/1988SE |
| K881130 | Cell-Dyn Isotonic DiluentGIF · Traditional | 03/31/1988SE |
| K873348 | Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic Ag.GGK · Traditional | 09/09/1987SE |
| K873408 | Model 690 SpectrophotometerJJQ · Traditional | 09/08/1987SE |
| K872761 | Cell-Dyn 610 Hematology AnalyzerGKZ · Traditional | 08/06/1987SE |
| K870233 | Cell-Dyn 1600 Multiparameter Auto. Hema. AnalyzerGKZ · Traditional | 03/17/1987SE |
Questions and answers
When was Cell-Dyn Diff. Screen Isotonic Diluent cleared by the FDA?
Cell-Dyn Diff. Screen Isotonic Diluent (K873347) received a 510(k) decision of Substantially Equivalent on September 9, 1987, 20 days after the submission was received.
What is the product code of K873347?
The FDA product code is GIF – Diluent, Blood Cell, a Class I (low risk) device regulated under 21 CFR 864.8200.