FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL 340 SPECTROPHOTOMETER
K Number: K822720
·
Decision Oct 8, 1982
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
28
Review Days
31
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Basic Information
- Device Name
- MODEL 340 SPECTROPHOTOMETER
- K Number
- K822720
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Diagnostics
- Date Received
- September 7, 1982
- Decision Date
- October 8, 1982
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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