FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNICON CELLTRACKS ANALYZER
K Number: K030263
·
Decision Nov 24, 2003
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
379
Applicant Total
6
Review Days
301
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Basic Information
- Device Name
- IMMUNICON CELLTRACKS ANALYZER
- K Number
- K030263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunicon Corp.
- Date Received
- January 27, 2003
- Decision Date
- November 24, 2003
- Product Code
- GKZ
- 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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | FDA class 2 | Hematology |
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Other Clearances by Immunicon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K060110 | CELLTRACKS ANALYZER II | Mar 16, 2006 | Substantially Equivalent |
| K050145 | CELLTRACKA ANALYZER II | Mar 15, 2005 | Substantially Equivalent |
| K040077 | IMMUNICON CELLTRACKS AUTOPREP SYSTEM | Mar 12, 2004 | Substantially Equivalent |
| K030596 | IMMUNICON CELLSAVE PRESERVATIVE TUBE | Aug 8, 2003 | Substantially Equivalent |
| K022512 | CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 | Sep 30, 2002 | Substantially Equivalent |