FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIA SOFTWARE
K Number: K832760
·
Decision Oct 14, 1983
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
77
Applicant Total
9
Review Days
56
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Basic Information
- Device Name
- RIA SOFTWARE
- K Number
- K832760
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Kemble Instruments, Inc.
- Date Received
- August 19, 1983
- Decision Date
- October 14, 1983
- Product Code
- JQP
- 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 |
|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Kemble Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K842894 | KEMBLE 405 | Aug 27, 1984 | Substantially Equivalent |
| K832734 | KEMTEK 400 RIA GAMMA COUNTER | Oct 14, 1983 | Substantially Equivalent |
| K832736 | KEMTEK 104 RIA GAMMA COUNTER | Sep 29, 1983 | Substantially Equivalent |
| K832735 | KEMTEK 103 RIA GAMMA COUNTER | Sep 29, 1983 | Substantially Equivalent |
| K830751 | KEMTEK 102 | Apr 6, 1983 | Substantially Equivalent |
| K822293 | IMMU-COUNT 404 | Aug 24, 1982 | Substantially Equivalent |
| K827748 | THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBE | Aug 16, 1982 | Substantially Equivalent |
| K820137 | IMMU-COUNT | Feb 5, 1982 | Substantially Equivalent |