FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CENTRIA SEPARATION COLUMNS TYPE A
K Number: K771118
·
Decision Jul 11, 1977
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
87
Applicant Total
8
Review Days
20
Basic Information
- Device Name
- CENTRIA SEPARATION COLUMNS TYPE A
- K Number
- K771118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- CLINICAL DIAGNOSTICS, INC.
- Date Received
- June 21, 1977
- Decision Date
- July 11, 1977
- Product Code
- CEM
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | FDA class 2 | Clinical Chemistry |
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| K761272 | CENTRIA T4 RIA | Mar 16, 1977 | Substantially Equivalent |