GKM · Hand-Tally, Differential
Hematology · 21 CFR 864.6160 · Class 1
Overview
| Product Code | GKM |
|---|---|
| Device Name | Hand-Tally, Differential |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K874188 | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA | Coulter Electronics, Inc. | Jan 19, 1988 | SESE |
| K854685 | DIGITAL-9 KEY LEUCOCYTE COUNTER | Future Impex Corp. | Apr 4, 1986 | SESE |
| K841026 | MANUAL BLOOD CELL COUNTING DEVICE | Instrumentation Laboratory CO | Apr 4, 1984 | SESE |
| K771580 | TEKTALLY II | Scientific Products | Sep 2, 1977 | SESE |
Top Applicants
- Coulter Electronics, Inc. — 1 clearance
- Future Impex Corp. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Scientific Products — 1 clearance
