Cell-Dyn Rapid-Lyse and Hemogloblin
FDA 510(k) K881242 · Abbott Diagnostics
510(k) numberK881242
Submission
- Device name
- Cell-Dyn Rapid-Lyse and Hemogloblin
- Applicant
- Abbott Diagnostics
Mountain View, CA, US - Received
- March 16, 1988
- Decision date
- April 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GJZ – Cyanomethemoglobin Reagent And Standard Solution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7500
- Specialty
- Hematology
Other 510(k)s with product code GJZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883683 | HemoglobinGJZ · Traditional | Tech-Co, Inc. | 10/06/1988SE |
More from Tech-Co, Inc.
| 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 |
| K881130 | Cell-Dyn Isotonic DiluentGIF · Traditional | 03/31/1988SE |
| K873348 | Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic Ag.GGK · Traditional | 09/09/1987SE |
| K873347 | Cell-Dyn Diff. Screen Isotonic DiluentGIF · 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 Rapid-Lyse and Hemogloblin cleared by the FDA?
Cell-Dyn Rapid-Lyse and Hemogloblin (K881242) received a 510(k) decision of Substantially Equivalent on April 21, 1988, 36 days after the submission was received.
What is the product code of K881242?
The FDA product code is GJZ – Cyanomethemoglobin Reagent And Standard Solution, a Class II (moderate risk) device regulated under 21 CFR 864.7500.