FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAT-20 FLUOROMETER
K Number: K882677
·
Decision Jul 12, 1988
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
1
Review Days
14
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Basic Information
- Device Name
- STAT-20 FLUOROMETER
- K Number
- K882677
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Weaver Medical
- Date Received
- June 28, 1988
- Decision Date
- July 12, 1988
- Product Code
- JZT
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZT | Fluorometer | FDA class 1 | Immunology |
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