FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
K Number: K972382
·
Decision Sep 14, 1998
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
1
Review Days
445
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Basic Information
- Device Name
- UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
- K Number
- K972382
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arrows Co., Ltd.
- Date Received
- June 26, 1997
- Decision Date
- September 14, 1998
- Product Code
- CIG
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
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