Hematology Calibrator S-Cal
FDA 510(k) K813375 · Coulter Electronics, Inc.
510(k) numberK813375
Submission
- Device name
- Hematology Calibrator S-Cal
- Applicant
- Coulter Electronics, Inc.
Mchenry, IL, US - Received
- December 1, 1981
- Decision date
- February 4, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KSA – Calibrator For Red-Cell And White-Cell Counting
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8185
- Specialty
- Hematology
Other 510(k)s with product code KSA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943268 | SCS-1000 (Sysmex Calibrator System)KSA · Traditional | Streck Laboratories, Inc. | 12/15/1994SE |
| K897060 | Cbc-Cal(Tm) Plus Hematology Calibrator/MultipleKSA · Traditional | R&D Systems, Inc. | 01/02/1990SE |
| K881161 | Tech-Cal(Tm)/MultipleKSA · Traditional | R&D Systems, Inc. | 05/02/1988SE |
| K864664 | H-1 Setpoint Platelet and Rbc/Wbc CalibratorsKSA · Traditional | Technicon Instruments Corp. | 02/06/1987SE |
| K854823 | Cbc-Cal/MultipleKSA · Traditional | R&D Systems, Inc. | 02/13/1986SE |
| K844708 | Tri-Count CalibratorKSA · Traditional | Hematology Marketing Assoc. | 03/05/1985SE |
| K813530 | Hemotology CalibratorKSA · Traditional | American Dade | 02/22/1982SE |
More from American Dade
| 510(k) | Device | Decision |
|---|---|---|
| K923951 | CD8 Cytospheres KitMAM · Traditional | 04/25/1994SE |
| K930119 | Coulter Retic-C Cell ControlJPK · Traditional | 04/05/1993SE |
| K921279 | CD4 Cytospheres KitGKZ · Traditional | 12/29/1992SE |
| K923530 | Coulter Multi-Q-PrepGKH · Traditional | 10/14/1992SE |
| K922181 | Coulter MH009GKZ · Traditional | 08/17/1992SE |
| K922704 | Coulter Maxm W/ AutoloaderGKZ · Traditional | 07/27/1992SE |
| K921567 | Coulter MH017GKZ · Traditional | 07/06/1992SE |
| K912133 | PX Coulter(R) Cell ControlJPK · Traditional | 07/17/1991SE |
| K911385 | Coulter(R) MH010GKZ · Traditional | 06/17/1991SE |
| K905771 | Coulter Dart Ast (Got) ReagentCIT · Traditional | 02/26/1991SE |
Questions and answers
When was Hematology Calibrator S-Cal cleared by the FDA?
Hematology Calibrator S-Cal (K813375) received a 510(k) decision of Substantially Equivalent on February 4, 1982, 65 days after the submission was received.
What is the product code of K813375?
The FDA product code is KSA – Calibrator For Red-Cell And White-Cell Counting, a Class II (moderate risk) device regulated under 21 CFR 864.8185.