Tri-Count Calibrator
FDA 510(k) K844708 · Hematology Marketing Assoc.
510(k) numberK844708
Submission
- Device name
- Tri-Count Calibrator
- Applicant
- Hematology Marketing Assoc.
Concord, CA, US - Received
- December 3, 1984
- Decision date
- March 5, 1985
- 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 |
| K813530 | Hemotology CalibratorKSA · Traditional | American Dade | 02/22/1982SE |
| K813375 | Hematology Calibrator S-CalKSA · Traditional | Coulter Electronics, Inc. | 02/04/1982SE |
More from Coulter Electronics, Inc.
| 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 |
| K850096 | Laser-GlobinGKR · Traditional | 03/29/1985SE |
| K850095 | Laser-DilGIF · Traditional | 03/29/1985SE |
| K850094 | Laser-Globin PowderGKR · Traditional | 03/29/1985SE |
| 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 Tri-Count Calibrator cleared by the FDA?
Tri-Count Calibrator (K844708) received a 510(k) decision of Substantially Equivalent on March 5, 1985, 92 days after the submission was received.
What is the product code of K844708?
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.