Tri-Count 16
FDA 510(k) K902389 · Hematronix, Inc.
510(k) numberK902389
Submission
- Device name
- Tri-Count 16
- Applicant
- Hematronix, Inc.
Plano, TX, US - Received
- May 30, 1990
- Decision date
- August 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JCN – Control, Cell Counter, Normal And Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code JCN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993825 | Para Tech Plus ReticsJCN · Traditional | Streck Laboratories, Inc. | 11/30/1999SE |
| K942209 | Liquichek HEMATOLOGY-16 Control, Low, Normal and HighJCN · Traditional | Bio-Rad | 06/16/1994SE |
| K934497 | Cbc-Stk(Tm) Hematology Control/MultipleJCN · Traditional | R&D Systems, Inc. | 12/06/1993SE |
| K911582 | Stak-ChexJCN · Traditional | Streck Laboratories, Inc. | 05/28/1991SE |
| K902391 | Cell-Dyn 3000 ControlJCN · Traditional | Unipath , Ltd. | 08/22/1990SE |
| K901875 | Para 12 PlusJCN · Traditional | Streck Laboratories, Inc. | 05/30/1990SE |
| K896154 | Para Tech for Technicon H-1JCN · Traditional | Streck Laboratories, Inc. | 11/09/1989SE |
| K895373 | Hematology ControlJCN · Traditional | Medical Specialties Intl., Inc. | 10/06/1989SE |
| K891907 | Qbc(R) Centrifugal Hematology Contr/Multi ModifiedJCN · Traditional | R&D Systems, Inc. | 04/11/1989SE |
| K874386 | Cbc-Tech(Tm) Hematology Control/MultipleJCN · Traditional | R&D Systems, Inc. | 12/30/1987SE |
More from R&D Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012243 | MCC Uricheck Assayed Liquid Urine Multiconstituent ControlJJY · Traditional | 08/20/2001SE |
| K993496 | Retic-QuinoxJPK · Traditional | 11/30/1999SE |
| K972710 | QUANTIFY(901)JJW · Traditional | 08/15/1997SE |
| K960471 | Tri-Count 20JPK · Traditional | 03/20/1996SE |
| K960005 | Tri-Court 20-TJPK · Traditional | 03/19/1996SE |
| K941965 | Ez-RangeJPK · Traditional | 04/25/1995SE |
| K935343 | Centrifiq Blood ControlJPK · Traditional | 01/27/1994SE |
| K904461 | Meter TraxJPK · Traditional | 10/26/1990SE |
Questions and answers
When was Tri-Count 16 cleared by the FDA?
Tri-Count 16 (K902389) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 84 days after the submission was received.
What is the product code of K902389?
The FDA product code is JCN – Control, Cell Counter, Normal And Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.8625.