FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEK-STIX U.T.I. SELF-TEST
K Number: K960888
·
Decision Jul 5, 1996
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
12
Applicant Total
96
Review Days
123
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Basic Information
- Device Name
- CHEK-STIX U.T.I. SELF-TEST
- K Number
- K960888
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1510
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- March 4, 1996
- Decision Date
- July 5, 1996
- Product Code
- JMT
- 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 |
|---|---|---|---|
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | FDA class 1 | Clinical Chemistry |
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