FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
LYNX EL MICROSCOPY TISSUE PROCESSOR
K Number: K862457
·
Decision Jul 16, 1986
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
4
Applicant Total
5
Review Days
16
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Basic Information
- Device Name
- LYNX EL MICROSCOPY TISSUE PROCESSOR
- K Number
- K862457
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Australian Biomedical Corporation , Ltd.
- Date Received
- June 30, 1986
- Decision Date
- July 16, 1986
- Product Code
- IDZ
- 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 |
|---|---|---|---|
| IDZ | Cassettes, Tissue | FDA class 1 | Pathology |
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