GJW · Pipette, Pasteur
Hematology · 21 CFR 864.6160 · Class 1
Overview
| Product Code | GJW |
|---|---|
| Device Name | Pipette, Pasteur |
| 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 |
|---|---|---|---|---|
| K896670 | TIP TOP(R) DISPENSER CAPS | Helena Laboratories | Mar 23, 1990 | SESE |
| K771138 | PIPETS BOROSILICATE GLASS | Dade, Baxter Travenol Diagnostics, Inc. | Aug 4, 1977 | SESE |
| K771137 | PIPETS UNIFORM DROP SIZE BOROSILICATE | Dade, Baxter Travenol Diagnostics, Inc. | Aug 4, 1977 | SESE |
| K760899 | STERILE DISPOSABLE COTTON PLUGGED SER. | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 9, 1976 | SESE |
Top Applicants
- Dade, Baxter Travenol Diagnostics, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Helena Laboratories — 1 clearance
