FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
K Number: K171476
·
Decision Feb 27, 2018
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
161
Applicant Total
18
Review Days
284
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Basic Information
- Device Name
- SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
- K Number
- K171476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Awareness Technology, Inc.
- Date Received
- May 19, 2017
- Decision Date
- February 27, 2018
- Product Code
- JGS
- 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 |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | FDA class 2 | Clinical Chemistry |
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Other Clearances by Awareness Technology, Inc.
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|---|---|---|---|
| K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | Jul 19, 2002 | Substantially Equivalent |
| K010877 | CHEMWELL, MODEL 2900 | May 23, 2001 | Substantially Equivalent |
| K974762 | STAT TRACKS | Jan 28, 1998 | Substantially Equivalent |
| K943729 | DYE CHECK STRIPS 545-630 | Dec 29, 1994 | Substantially Equivalent |
| K941394 | STAT FAX 2600 | Jun 3, 1994 | Substantially Equivalent |
| K923598 | REDI-CHECK PHOTMETER Q.A. | Oct 14, 1992 | Substantially Equivalent |
| K900224 | STAT FAX(TM)-2100 | Mar 1, 1990 | Substantially Equivalent |
| K892656 | DRI-DYE CHECK STRIPS (TM)-405 | May 22, 1989 | Substantially Equivalent |
| K882938 | STAT FAX(TM) | Sep 9, 1988 | Substantially Equivalent |
| K873451 | PROJECT 300 MICROASSAY BP-12, EIA MINILAB | Nov 4, 1987 | Substantially Equivalent |