FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
C. DIFF QUIK CHEK COMPLETE
K Number: K082499
·
Decision Mar 26, 2009
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
41
Applicant Total
36
Review Days
209
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Basic Information
- Device Name
- C. DIFF QUIK CHEK COMPLETE
- K Number
- K082499
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techlab, Inc.
- Date Received
- August 29, 2008
- Decision Date
- March 26, 2009
- Product Code
- LLH
- 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 |
|---|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | 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 |
| K173217 | CAMPYLOBACTER QUIK CHEK | Jan 22, 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 |
| K053572 | C. DIFF QUIK CHEK | Apr 26, 2006 | Substantially Equivalent |
| K051927 | TECHLAB ASCA-CHEK | Apr 6, 2006 | Substantially Equivalent |