FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLIDESCAN
K Number: K001420
·
Decision Aug 30, 2000
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
34
Applicant Total
7
Review Days
117
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Basic Information
- Device Name
- SLIDESCAN
- K Number
- K001420
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5260
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Imaging Corp.
- Date Received
- May 5, 2000
- Decision Date
- August 30, 2000
- Product Code
- JOY
- 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 |
|---|---|---|---|
| JOY | Device, Automated Cell-Locating | FDA class 2 | Hematology |
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Other Clearances by Applied Imaging Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K043519 | ARIOL HER-2/NEU FISH | Apr 25, 2005 | Substantially Equivalent |
| K042542 | CYTOVISION FOR CEP XY | Jan 10, 2005 | Substantially Equivalent |
| K033200 | ARIOL | Mar 18, 2004 | Substantially Equivalent |
| K031715 | ARIOL HER-2/NEU IHC | Jan 8, 2004 | Substantially Equivalent |
| K980375 | WINSCAN AUTOMATED IMAGING SYSTEM | Jun 9, 1998 | Substantially Equivalent |
| K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | Aug 20, 1990 | Substantially Equivalent |