GLG · Platelet Counting, Manual
Hematology · 21 CFR 864.6160 · Class 1
Overview
| Product Code | GLG |
|---|---|
| Device Name | Platelet Counting, Manual |
| Regulation | 21 CFR 864.6160 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.
Classification Rationale
Class I (general controls). This 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K842921 | REES & ECKER DILUTION FLUID | E K Ind., Inc. | Sep 7, 1984 | SESE |
| K811084 | LABTRONIX PLATELET COUNTER(L/O/C.) | Labtronix Corp. | Jul 23, 1981 | SESE |
| K772105 | PLATELET KIT | Streck Laboratories, Inc. | Nov 30, 1977 | SESE |
Top Applicants
- E K Ind., Inc. — 1 clearance
- Labtronix Corp. — 1 clearance
- Streck Laboratories, Inc. — 1 clearance
