FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINI S.F.T. (URINE PRESERVATIVE)
K Number: K943466
·
Decision May 24, 1995
Classifications
1
FEI Numbers
303
Registration Numbers
304
Same Product Code
2
Applicant Total
1
Review Days
343
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Basic Information
- Device Name
- MINI S.F.T. (URINE PRESERVATIVE)
- K Number
- K943466
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cambridge Diagnostic Products, Inc.
- Date Received
- June 15, 1994
- Decision Date
- May 24, 1995
- Product Code
- LXG
- 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 |
|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXG), ordered by most recent decision date.
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