FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIGOLD GIARDIA
K Number: K120001
·
Decision Mar 1, 2013
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
26
Applicant Total
5
Review Days
423
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Basic Information
- Device Name
- UNIGOLD GIARDIA
- K Number
- K120001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trinity Biotech
- Date Received
- January 3, 2012
- Decision Date
- March 1, 2013
- 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
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IVD CRYPTO/GIARDIA DFA
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Other Clearances by Trinity Biotech
| K Number | Device Name | ||
|---|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | Oct 23, 2017 | Substantially Equivalent |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | Feb 1, 2017 | Substantially Equivalent |
| K121565 | UNI-GOLD CRYPTOSPORIDIUM | Feb 8, 2013 | Substantially Equivalent |
| K083896 | DESTINY MAX COAGULATION ANALYZER | Jul 2, 2009 | Substantially Equivalent |