FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRI-COMBO PARASITE SCREEN
K Number: K171078
·
Decision Jul 10, 2017
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
36
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TRI-COMBO PARASITE SCREEN
- K Number
- K171078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techlab, Inc.
- Date Received
- April 11, 2017
- Decision Date
- July 10, 2017
- Product Code
- MHJ
- 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 |
|---|---|---|---|
| MHJ | Cryptosporidium Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MHJ), ordered by most recent decision date.
UNI-GOLD CRYPTOSPORIDIUM
FDA 510(k)
FDA Class 2
·Microbiology
GIARDIA/CRYPTOSPORIDIUM CHEK
FDA 510(k)
FDA Class 2
·Microbiology
CRYPTOSPORIDIUM II
FDA 510(k)
FDA Class 2
·Microbiology
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
FDA 510(k)
FDA Class 2
·Microbiology
IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
FDA 510(k)
FDA Class 2
·Microbiology
PREMIER CRYPTOSPORIDIUM
FDA 510(k)
FDA Class 2
·Microbiology
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 |
| 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 |