FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMAVIEW DARKFIELD MICROSCOPE SYSTEM
K Number: K885091
·
Decision Jun 13, 1989
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
0
Applicant Total
3
Review Days
183
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Basic Information
- Device Name
- HEMAVIEW DARKFIELD MICROSCOPE SYSTEM
- K Number
- K885091
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3600
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Technalysis, Inc.
- Date Received
- December 12, 1988
- Decision Date
- June 13, 1989
- Product Code
- IBM
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| IBM | Microscope, Phase Contrast | FDA class 1 | Pathology |