FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTROPHOTOMETER #390
K Number: K832206
·
Decision Aug 24, 1983
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
28
Review Days
48
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Basic Information
- Device Name
- SPECTROPHOTOMETER #390
- K Number
- K832206
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Diagnostics
- Date Received
- July 7, 1983
- Decision Date
- August 24, 1983
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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