GKM — Hand-Tally, Differential Class I
FDA Device Classification
Classification Details
- Product Code
- GKM
- Device Class
- Class I
- Regulation Number
- 864.6160
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K874188 | coulter electronics | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA | January 19, 1988 |
| K854685 | future impex | DIGITAL-9 KEY LEUCOCYTE COUNTER | April 4, 1986 |
| K841026 | instrumentation laboratory | MANUAL BLOOD CELL COUNTING DEVICE | April 4, 1984 |
| K771580 | scientific products | TEKTALLY II | September 2, 1977 |