FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROTATOR, FIXED SPEED
K Number: K760467
·
Decision Oct 29, 1976
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
3
Review Days
72
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Basic Information
- Device Name
- ROTATOR, FIXED SPEED
- K Number
- K760467
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Lederle Laboratories
- Date Received
- August 18, 1976
- Decision Date
- October 29, 1976
- 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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