Control, Cell Counter, Normal And Abnormal
Normal and abnormal cell counter controls are reference materials used to verify the performance of automated hematology analyzers by providing samples with known blood cell counts and indices at both normal and abnormal levels, ensuring instrument accuracy and reliability. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JCN, regulated under 21 CFR 864.8625, within the Hematology medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- JCN
- Device Class
- FDA class 2
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K993825 | PARA TECH PLUS RETICS | Nov 30, 1999 | Substantially Equivalent | STRECK LABORATORIES, INC. |
| K942209 | LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH | Jun 16, 1994 | Substantially Equivalent | BIO-RAD |
| K934497 | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE | Dec 06, 1993 | Substantially Equivalent | R & D SYSTEMS, INC. |
| K911582 | STAK-CHEX | May 28, 1991 | Substantially Equivalent | STRECK LABORATORIES, INC. |
| K902391 | CELL-DYN 3000 CONTROL | Aug 22, 1990 | Substantially Equivalent | UNIPATH LTD. |
| K902389 | TRI-COUNT 16 | Aug 22, 1990 | Substantially Equivalent | HEMATRONIX, INC. |
| K901875 | PARA 12 PLUS | May 30, 1990 | Substantially Equivalent | STRECK LABORATORIES, INC. |
| K896154 | PARA TECH FOR TECHNICON H-1 | Nov 09, 1989 | Substantially Equivalent | STRECK LABORATORIES, INC. |
| K895373 | HEMATOLOGY CONTROL | Oct 06, 1989 | Substantially Equivalent | MEDICAL SPECIALTIES INTL., INC. |
| K891907 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED | Apr 11, 1989 | Substantially Equivalent | R & D SYSTEMS, INC. |
| K874386 | CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE | Dec 30, 1987 | Substantially Equivalent | R & D SYSTEMS, INC. |
| K821956 | HAEM-C PLUS BLOOD REFERENCE CONTROLS | Jul 30, 1982 | Substantially Equivalent | BAKER INSTRUCTIONS CORP. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.