FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXETRELUT
K Number: K782066
·
Decision Jan 3, 1979
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
8
Applicant Total
5
Review Days
21
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Basic Information
- Device Name
- EXETRELUT
- K Number
- K782066
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2230
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Mcb Manufacturing Chemists, Inc.
- Date Received
- December 13, 1978
- Decision Date
- January 3, 1979
- Product Code
- KEA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| KEA | Resins, Ion-Exchange | FDA class 1 | Clinical Chemistry |
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