21 CFR 864.6160 — Pipette, Sahli
Hematology (HE) · Part 864 Subpart G—Manual Hematology Devices · § 864.6160
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GGX | Pipette, Sahli | 1 | 2 | |
| GGY | Pipette, Diluting | 1 | 0 | |
| GHO | Hemocytometer | 1 | 2 | |
| GJG | Pipette, Quantitative, Hematology | 1 | 4 | |
| GJW | Pipette, Pasteur | 1 | 4 | |
| GKM | Hand-Tally, Differential | 1 | 4 | |
| GLG | Platelet Counting, Manual | 1 | 3 |
