FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOYO JOZO URIC ACID TEST
K Number: K842103
·
Decision Aug 12, 1984
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
117
Applicant Total
13
Review Days
79
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Basic Information
- Device Name
- TOYO JOZO URIC ACID TEST
- K Number
- K842103
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Advocacy International, Ltd.
- Date Received
- May 25, 1984
- Decision Date
- August 12, 1984
- Product Code
- KNK
- 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 |
|---|---|---|---|
| KNK | Acid, Uric, Uricase (Colorimetric) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Advocacy International, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K874027 | LIPASE UV [TOYO] | May 27, 1988 | Substantially Equivalent |
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| K855251 | MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS | Feb 4, 1986 | Substantially Equivalent |
| K855212 | ASAHI AM SERIES DIALYZERS | Jan 21, 1986 | Substantially Equivalent |
| K854259 | SEPACELL R-500 & SEPACELL R-500A | Jan 8, 1986 | Substantially Equivalent |
| K842104 | TOYO JOZO G-GTP TEST | Aug 10, 1984 | Substantially Equivalent |
| K830183 | ASAHI HOLLOW FIBER KIDNEYS NR SERIES | Mar 17, 1983 | Substantially Equivalent |
| K830231 | ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES | Mar 17, 1983 | Substantially Equivalent |
| K823733 | EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR | Jan 14, 1983 | Substantially Equivalent |
| K813037 | FLOWGUARD CATHETERS & CANNALAE | Dec 14, 1981 | Substantially Equivalent |