FDA Product Code
FDA Product Code GKM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.6160
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K874188 | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA | Coulter Electronics, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K854685 | DIGITAL-9 KEY LEUCOCYTE COUNTER | Future Impex Corp. | 1986-04-04 | Traditional | PDF ↗ |
| K841026 | MANUAL BLOOD CELL COUNTING DEVICE | Instrumentation Laboratory CO | 1984-04-04 | Traditional | PDF ↗ |
| K771580 | TEKTALLY II | Scientific Products | 1977-09-02 | Traditional | PDF ↗ |
Product code GKM · Class I · Hematology. Data: openFDA.