Product Code: GGX FDA class 1 21 CFR 864.6160

Pipette, Sahli

Hematology

The Pipette, Sahli (product code GGX) is a manual glass capillary pipette used historically in the Sahli acid hematin method for measuring hemoglobin concentration in blood samples in hematology laboratories. 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
2
FEI Numbers
1
Registration Numbers
1
Unique Applicants
2
Years Active
1

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Basic Information

Product Code
GGX
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 2 510(k) clearances via K numbers.

K Number Device Name
K902263 OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
K894389 CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS

FEI Numbers

This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.