Product Code: GJW FDA class 1 21 CFR 864.6160

Pipette, Pasteur

Hematology

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.

510(k)s
4
FEI Numbers
26
Registration Numbers
26
Unique Applicants
3
Years Active
13

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number Device Name
K896670 TIP TOP(R) DISPENSER CAPS
K771138 PIPETS BOROSILICATE GLASS
K771137 PIPETS UNIFORM DROP SIZE BOROSILICATE
K760899 STERILE DISPOSABLE COTTON PLUGGED SER.

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.