FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
LUMICO ANALYZER SA-300
K Number: K923158
·
Decision Nov 17, 1992
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
1
Review Days
141
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Basic Information
- Device Name
- LUMICO ANALYZER SA-300
- K Number
- K923158
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maruzen Petrochemical Co., Ltd.
- Date Received
- June 29, 1992
- Decision Date
- November 17, 1992
- 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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