FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINE TESTER, MODEL NO. 707
K Number: K770423
·
Decision Jun 3, 1977
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
8
Applicant Total
2
Review Days
88
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Basic Information
- Device Name
- URINE TESTER, MODEL NO. 707
- K Number
- K770423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1800
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Brother Scientific Products, Inc.
- Date Received
- March 7, 1977
- Decision Date
- June 3, 1977
- Product Code
- EXR
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| EXR | Urinometer, Mechanical | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Brother Scientific Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K770939 | URINE TESTER, MODEL 701 | Jun 3, 1977 | Substantially Equivalent |