FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTANT EOSIN-ALCOHOLIC
K Number: K880240
·
Decision Mar 3, 1988
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
9
Applicant Total
5
Review Days
43
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Basic Information
- Device Name
- INSTANT EOSIN-ALCOHOLIC
- K Number
- K880240
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Shandon, Inc.
- Date Received
- January 20, 1988
- Decision Date
- March 3, 1988
- Product Code
- HYB
- 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 |
|---|---|---|---|
| HYB | Eosin Y | FDA class 1 | Hematology |
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