FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIGITAL-9 KEY LEUCOCYTE COUNTER
K Number: K854685
·
Decision Apr 4, 1986
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
3
Applicant Total
14
Review Days
135
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Basic Information
- Device Name
- DIGITAL-9 KEY LEUCOCYTE COUNTER
- K Number
- K854685
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6160
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Future Impex Corp.
- Date Received
- November 20, 1985
- Decision Date
- April 4, 1986
- Product Code
- GKM
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GKM | Hand-Tally, Differential | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKM), ordered by most recent decision date.
COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA
FDA 510(k)
FDA Class 1
·Hematology
MANUAL BLOOD CELL COUNTING DEVICE
FDA 510(k)
FDA Class 1
·Hematology
TEKTALLY II
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Future Impex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K861487 | ST-90 SPIRO ANALIZER | Jun 23, 1986 | Substantially Equivalent |
| K854686 | TE-25 COAGURO METER | Jun 4, 1986 | Substantially Equivalent |
| K854687 | ERMA HB-METER MODEL 303N | Jun 4, 1986 | Substantially Equivalent |
| K854678 | ERMA PC-602 PC-603 BLOOD CELL COUNTER | Feb 24, 1986 | Substantially Equivalent |
| K854677 | ERMA PC-604 BLOOD CELL COUNTER | Feb 24, 1986 | Substantially Equivalent |
| K854679 | PHOTIC-100 SPECTROPHOTOMETER | Feb 20, 1986 | Substantially Equivalent |
| K843934 | MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT | Nov 20, 1984 | Substantially Equivalent |
| K843984 | PM-80 PULMOTESTER | Oct 24, 1984 | Substantially Equivalent |
| K843700 | ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- | Oct 24, 1984 | Substantially Equivalent |
| K832433 | AUTOMATIC SPIROMETER ST-200 | Sep 29, 1983 | Substantially Equivalent |