FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRAFREE-CL
K Number: K941326
·
Decision May 27, 1994
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
14
Applicant Total
30
Review Days
70
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Basic Information
- Device Name
- ULTRAFREE-CL
- K Number
- K941326
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2310
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Millipore Corp.
- Date Received
- March 18, 1994
- Decision Date
- May 27, 1994
- Product Code
- JJH
- 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 |
|---|---|---|---|
| JJH | Clinical Sample Concentrator | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJH), ordered by most recent decision date.
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