FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NUCLEAR SAMPLE READER
K Number: K790905
·
Decision Jun 15, 1979
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
883
Review Days
35
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Basic Information
- Device Name
- NUCLEAR SAMPLE READER
- K Number
- K790905
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- May 11, 1979
- Decision Date
- June 15, 1979
- 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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