FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SELECTA 20/60 CHEMISTRY ANALYZER
K Number: K942922
·
Decision Jul 19, 1995
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
6
Review Days
393
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Basic Information
- Device Name
- SELECTA 20/60 CHEMISTRY ANALYZER
- K Number
- K942922
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Select Medical Systems, Inc.
- Date Received
- June 21, 1994
- Decision Date
- July 19, 1995
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Select Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012935 | THECURVE, ITEM 507 | Oct 11, 2001 | Substantially Equivalent |
| K974819 | SELECTCELLS(TM) MINI | Mar 23, 1998 | Substantially Equivalent |
| K954099 | SELECT IUI | Nov 22, 1995 | Substantially Equivalent |
| K954097 | SELECTCELLS STANDARD | Nov 21, 1995 | Substantially Equivalent |
| K954102 | SELECTMUCUS | Nov 21, 1995 | Substantially Equivalent |