GJG · Pipette, Quantitative, Hematology
Hematology · 21 CFR 864.6160 · Class 1
Overview
| Product Code | GJG |
|---|---|
| Device Name | Pipette, Quantitative, Hematology |
| 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 |
|---|---|---|---|---|
| K831079 | LIQUIPETTE | The Kendall Company Div. of Tyco Healthcare Group | Apr 28, 1983 | SESE |
| K781891 | PIPETTES, PLASTIC DISPOSABLE | Hillwood Corp. | Nov 15, 1978 | SESE |
| K780237 | DISPOSABLE CONTROLLED DROP PASTEUR PIPET | Owens-Illinois, Inc. | Mar 9, 1978 | SESE |
| K760719 | UNIFORM DROP SIZE PASTEUR TYPE PIPETS | Dade, Baxter Travenol Diagnostics, Inc. | Oct 29, 1976 | SESE |
Top Applicants
- Dade, Baxter Travenol Diagnostics, Inc. — 1 clearance
- Hillwood Corp. — 1 clearance
- Owens-Illinois, Inc. — 1 clearance
- The Kendall Company Div. of Tyco Healthcare Group — 1 clearance
