Pipette, Pasteur
The Pipette, Pasteur (product code GJW) is a simple disposable or reusable glass or plastic transfer pipette used in hematology and clinical laboratories for transferring small volumes of liquids without precise volumetric measurement. 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
- GJW
- 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 |
|---|---|---|---|---|
| K896670 | TIP TOP(R) DISPENSER CAPS | Mar 23, 1990 | Substantially Equivalent | Helena Laboratories |
| K771138 | PIPETS BOROSILICATE GLASS | Aug 04, 1977 | Substantially Equivalent | Dade, Baxter Travenol Diagnostics, Inc. |
| K771137 | PIPETS UNIFORM DROP SIZE BOROSILICATE | Aug 04, 1977 | Substantially Equivalent | Dade, Baxter Travenol Diagnostics, Inc. |
| K760899 | STERILE DISPOSABLE COTTON PLUGGED SER. | Nov 09, 1976 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.