FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CENTIDISC
K Number: K813524
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
3
Review Days
15
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Basic Information
- Device Name
- CENTIDISC
- K Number
- K813524
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bel-Art Products
- Date Received
- December 16, 1981
- Decision Date
- December 31, 1981
- Product Code
- JQC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | FDA class 1 | Clinical Chemistry |
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