FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEGACOLOR
K Number: K860319
·
Decision Feb 20, 1986
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
15
Applicant Total
5
Review Days
23
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Basic Information
- Device Name
- MEGACOLOR
- K Number
- K860319
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Cytocolor, Inc.
- Date Received
- January 28, 1986
- Decision Date
- February 20, 1986
- Product Code
- LED
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| LED | Stains, Chemical Solution | FDA class 1 | Hematology |
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