JCN · Control, Cell Counter, Normal And Abnormal
Hematology · 21 CFR 864.8625 · Class 2
Overview
| Product Code | JCN |
|---|---|
| Device Name | Control, Cell Counter, Normal And Abnormal |
| Regulation | 21 CFR 864.8625 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
Classification Rationale
Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K993825 | PARA TECH PLUS RETICS | Streck Laboratories, Inc. | Nov 30, 1999 | SESE |
| K942209 | LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH | Bio-Rad | Jun 16, 1994 | SESE |
| K934497 | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | Dec 6, 1993 | SESE |
| K911582 | STAK-CHEX | Streck Laboratories, Inc. | May 28, 1991 | SESE |
| K902391 | CELL-DYN 3000 CONTROL | Unipath , Ltd. | Aug 22, 1990 | SESE |
| K902389 | TRI-COUNT 16 | Hematronix, Inc. | Aug 22, 1990 | SESE |
| K901875 | PARA 12 PLUS | Streck Laboratories, Inc. | May 30, 1990 | SESE |
| K896154 | PARA TECH FOR TECHNICON H-1 | Streck Laboratories, Inc. | Nov 9, 1989 | SESE |
| K895373 | HEMATOLOGY CONTROL | Medical Specialties Intl., Inc. | Oct 6, 1989 | SESE |
| K891907 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED | R&D Systems, Inc. | Apr 11, 1989 | SESE |
| K874386 | CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | Dec 30, 1987 | SESE |
| K821956 | HAEM-C PLUS BLOOD REFERENCE CONTROLS | Baker Instructions Corp. | Jul 30, 1982 | SESE |
Top Applicants
- Streck Laboratories, Inc. — 4 clearances
- R&D Systems, Inc. — 3 clearances
- Baker Instructions Corp. — 1 clearance
- Bio-Rad — 1 clearance
- Hematronix, Inc. — 1 clearance
