FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FA TISSUE FIXATIVE & WASH SET
K Number: K761138
·
Decision Jan 6, 1978
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
7
Applicant Total
135
Review Days
406
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Basic Information
- Device Name
- FA TISSUE FIXATIVE & WASH SET
- K Number
- K761138
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Zeus Scientific, Inc.
- Date Received
- November 26, 1976
- Decision Date
- January 6, 1978
- Product Code
- LDZ
- 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 |
|---|---|---|---|
| LDZ | Fixative, Alcohol Containing | FDA class 1 | Pathology |
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