GKM
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hand-Tally, Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6160
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA (K874188) | Coulter Electronics, Inc. | 1988-01-19 |
| DIGITAL-9 KEY LEUCOCYTE COUNTER (K854685) | Future Impex Corp. | 1986-04-04 |
| MANUAL BLOOD CELL COUNTING DEVICE (K841026) | Instrumentation Laboratory CO | 1984-04-04 |
| TEKTALLY II (K771580) | Scientific Products | 1977-09-02 |
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