Hematology Control
FDA 510(k) K895373 · Medical Specialties Intl., Inc.
510(k) numberK895373
Submission
- Device name
- Hematology Control
- Applicant
- Medical Specialties Intl., Inc.
South Plainfield, NJ, US - Received
- August 29, 1989
- Decision date
- October 6, 1989
- 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 |
| K902389 | Tri-Count 16JCN · Traditional | Hematronix, Inc. | 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 |
| 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.
Questions and answers
When was Hematology Control cleared by the FDA?
Hematology Control (K895373) received a 510(k) decision of Substantially Equivalent on October 6, 1989, 38 days after the submission was received.
What is the product code of K895373?
The FDA product code is JCN – Control, Cell Counter, Normal And Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.8625.