DIGITAL-9 KEY LEUCOCYTE COUNTER
FDA 510(k) clearance K854685 · decided 1986-04-04
Clearance details
- K-number
- K854685
- Device name
- DIGITAL-9 KEY LEUCOCYTE COUNTER
- Applicant
- Future Impex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-20
- Decision date
- 1986-04-04
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- GKM
- Device class
- 1
- Regulation number
- 864.6160
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Deerpark, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA (K874188) | Coulter Electronics, Inc. | 1988-01-19 |
| MANUAL BLOOD CELL COUNTING DEVICE (K841026) | Instrumentation Laboratory CO | 1984-04-04 |
| TEKTALLY II (K771580) | Scientific Products | 1977-09-02 |
Recalls involving this device
No recalls on record reference this clearance.