Hand-Tally, Differential
The Hand-Tally, Differential (product code GKM) is a manual counting device used by laboratory personnel to record cell counts during manual differential blood count examination under a microscope, tracking each leukocyte type encountered across a defined number of cells. 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
- GKM
- 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 |
|---|---|---|---|---|
| K874188 | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA | Jan 19, 1988 | Substantially Equivalent | Coulter Electronics, Inc. |
| K854685 | DIGITAL-9 KEY LEUCOCYTE COUNTER | Apr 04, 1986 | Substantially Equivalent | Future Impex Corp. |
| K841026 | MANUAL BLOOD CELL COUNTING DEVICE | Apr 04, 1984 | Substantially Equivalent | Instrumentation Laboratory CO |
| K771580 | TEKTALLY II | Sep 02, 1977 | Substantially Equivalent | Scientific Products |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.