FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAMPYLOBACTER QUIK CHEK
K Number: K173217
·
Decision Jan 22, 2018
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
11
Applicant Total
36
Review Days
111
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Basic Information
- Device Name
- CAMPYLOBACTER QUIK CHEK
- K Number
- K173217
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techlab, Inc.
- Date Received
- October 3, 2017
- Decision Date
- January 22, 2018
- Product Code
- LQP
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LQP | Campylobacter Spp. | FDA class 1 | Microbiology |
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Other Clearances by Techlab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K191442 | Campylobacter Chek | Jun 20, 2019 | Substantially Equivalent |
| K191456 | Campylobacter Quik Chek | Jun 20, 2019 | Substantially Equivalent |
| K181400 | H. PYLORI CHEK | Aug 21, 2018 | Substantially Equivalent |
| K181379 | H. PYLORI QUIK CHEK | Aug 21, 2018 | Substantially Equivalent |
| K173219 | CAMPYLOBACTER CHEK | Jan 22, 2018 | Substantially Equivalent |
| K171078 | TRI-COMBO PARASITE SCREEN | Jul 10, 2017 | Substantially Equivalent |
| K170728 | E. HISTOLYTICA QUIK CHEK | Jun 7, 2017 | Substantially Equivalent |
| K082499 | C. DIFF QUIK CHEK COMPLETE | Mar 26, 2009 | Substantially Equivalent |
| K053572 | C. DIFF QUIK CHEK | Apr 26, 2006 | Substantially Equivalent |
| K051927 | TECHLAB ASCA-CHEK | Apr 6, 2006 | Substantially Equivalent |