FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UROCYSTIN
K Number: K843382
·
Decision Jan 8, 1985
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
3
Review Days
133
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Basic Information
- Device Name
- UROCYSTIN
- K Number
- K843382
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1240
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Mission Pharmacal Co.
- Date Received
- August 28, 1984
- Decision Date
- January 8, 1985
- Product Code
- JLC
- 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 |
|---|---|---|---|
| JLC | Nitroprusside Reaction (Qualitative, Urine), Cystine | FDA class 1 | Clinical Chemistry |
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