Pipette, Quantitative, Hematology
The Pipette, Quantitative, Hematology (product code GJG) is a precision calibrated pipette used in hematology laboratories to accurately transfer measured volumes of blood or reagents for quantitative analyses such as cell counting, hemoglobin measurement, and coagulation testing. This device is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. Regulated under 21 CFR 864.6160 in the Hematology specialty (HE), this device carries no special regulatory flags.
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Basic Information
- Product Code
- GJG
- Device Class
- FDA class 1
- Regulation Number
- 864.6160
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K831079 | LIQUIPETTE | Apr 28, 1983 | Substantially Equivalent | The Kendall Company Div. of Tyco Healthcare Group |
| K781891 | PIPETTES, PLASTIC DISPOSABLE | Nov 15, 1978 | Substantially Equivalent | Hillwood Corp. |
| K780237 | DISPOSABLE CONTROLLED DROP PASTEUR PIPET | Mar 09, 1978 | Substantially Equivalent | Owens-Illinois, Inc. |
| K760719 | UNIFORM DROP SIZE PASTEUR TYPE PIPETS | Oct 29, 1976 | Substantially Equivalent | Dade, Baxter Travenol Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.