FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GIARDIA II
K Number: K033274
·
Decision Nov 4, 2003
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
26
Applicant Total
36
Review Days
25
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Basic Information
- Device Name
- GIARDIA II
- K Number
- K033274
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Techlab, Inc.
- Date Received
- October 10, 2003
- Decision Date
- November 4, 2003
- Product Code
- MHI
- 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 |
|---|---|---|---|
| MHI | Giardia Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MHI), ordered by most recent decision date.
UNIGOLD GIARDIA
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GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
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XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
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XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
IVD CRYPTO/GIARDIA DFA
FDA 510(k)
FDA Class 2
·Microbiology
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| 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 |
| K082499 | C. DIFF QUIK CHEK COMPLETE | Mar 26, 2009 | Substantially Equivalent |
| K053572 | C. DIFF QUIK CHEK | Apr 26, 2006 | Substantially Equivalent |