FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CENTRICELL(TM)
K Number: K871290
·
Decision Aug 5, 1987
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
14
Applicant Total
3
Review Days
127
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Basic Information
- Device Name
- CENTRICELL(TM)
- K Number
- K871290
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2310
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Polysciences, Inc.
- Date Received
- March 31, 1987
- Decision Date
- August 5, 1987
- 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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