GGX · Pipette, Sahli
Hematology · 21 CFR 864.6160 · Class 1
Overview
| Product Code | GGX |
|---|---|
| Device Name | Pipette, Sahli |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K902263 | OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION | Trimedyne, Inc. | Jul 23, 1990 | SESE |
| K894389 | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS | Catachem, Inc. | Oct 12, 1989 | SESE |
Top Applicants
- Catachem, Inc. — 1 clearance
- Trimedyne, Inc. — 1 clearance
