FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NIKON URINE REFRACTOMER SG-1
K Number: K802959
·
Decision Dec 19, 1980
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
12
Applicant Total
2
Review Days
29
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Basic Information
- Device Name
- NIKON URINE REFRACTOMER SG-1
- K Number
- K802959
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2800
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nippon Kogaku, Inc.
- Date Received
- November 20, 1980
- Decision Date
- December 19, 1980
- Product Code
- JRE
- 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 |
|---|---|---|---|
| JRE | Refractometer For Clinical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRE), ordered by most recent decision date.
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Other Clearances by Nippon Kogaku, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802958 | AUTO REFRACTOMETER NR-1000 | Apr 23, 1981 | Substantially Equivalent |