FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLAME PHOTOMETERS
K Number: K834226
·
Decision Jun 22, 1984
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
21
Applicant Total
5
Review Days
199
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Basic Information
- Device Name
- FLAME PHOTOMETERS
- K Number
- K834226
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2540
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dr. Bruno Lange GmbH
- Date Received
- December 6, 1983
- Decision Date
- June 22, 1984
- Product Code
- JJO
- 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 |
|---|---|---|---|
| JJO | Flame Emission Photometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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