GGL · Control, White-Cell
Hematology · 21 CFR 864.8625 · Class 2
Overview
| Product Code | GGL |
|---|---|
| Device Name | Control, White-Cell |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K083926 | CD4 COUNT | Streck | Feb 11, 2009 | SESE |
| K051633 | CD-CHEX PLUS BC | Streck | Aug 16, 2005 | SESE |
| K993126 | CD-CHEX CD 34 | Streck Laboratories, Inc. | Nov 26, 1999 | SESE |
| K960894 | CD-CHEX + RBC | Streck Laboratories, Inc. | May 24, 1996 | SESE |
| K931825 | CD-CHEX CD4 LOW | Streck Laboratories, Inc. | Jun 6, 1994 | SESE |
| K920997 | CD-CHEX | Streck Laboratories, Inc. | May 31, 1992 | SESE |
| K894651 | COULTER POSITIVE CONTROL CELLS | Coulter Corp. | Sep 13, 1989 | SESE |
| K891175 | EDL ABNORMAL COAGULATION CONTROL | Elite Diagnostic , Ltd. | Apr 10, 1989 | SESE |
Top Applicants
- Streck Laboratories, Inc. — 4 clearances
- Streck — 2 clearances
- Coulter Corp. — 1 clearance
- Elite Diagnostic , Ltd. — 1 clearance
