FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UA-Cellular Complete
K Number: K170091
·
Decision Feb 9, 2017
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
33
Review Days
30
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Basic Information
- Device Name
- UA-Cellular Complete
- K Number
- K170091
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Streck
- Date Received
- January 10, 2017
- Decision Date
- February 9, 2017
- Product Code
- JJW
- 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 |
|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K231223 | MDx-Chex for BC-GN | Jul 27, 2023 | Substantially Equivalent |
| K231221 | MDx-Chex for BC-GP | Jul 27, 2023 | Substantially Equivalent |
| K160588 | XN CHECK BF | Dec 22, 2016 | Substantially Equivalent |
| K160586 | XN-L CHECK | Dec 22, 2016 | Substantially Equivalent |
| K160585 | XN CAL | Dec 22, 2016 | Substantially Equivalent |
| K160590 | XN CHECK | Dec 22, 2016 | Substantially Equivalent |
| K141957 | XN CHECK BF | Dec 5, 2014 | Substantially Equivalent |
| K141964 | XN CHECK | Dec 5, 2014 | Substantially Equivalent |
| K141962 | XN CAL | Dec 5, 2014 | Substantially Equivalent |