FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NUCLEAR ENTERPRISES 1612 MULTI-WELL
K Number: K801263
·
Decision Jun 20, 1980
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
3
Review Days
23
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Basic Information
- Device Name
- NUCLEAR ENTERPRISES 1612 MULTI-WELL
- K Number
- K801263
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nuclear Ent. , Ltd.
- Date Received
- May 28, 1980
- Decision Date
- June 20, 1980
- Product Code
- JJJ
- 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 |
|---|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | FDA class 1 | Clinical Chemistry |
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