FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNI-GOLD CRYPTOSPORIDIUM
K Number: K121565
·
Decision Feb 8, 2013
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
5
Review Days
255
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Basic Information
- Device Name
- UNI-GOLD CRYPTOSPORIDIUM
- K Number
- K121565
- 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
- May 29, 2012
- Decision Date
- February 8, 2013
- 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 |
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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 |
| K120001 | UNIGOLD GIARDIA | Mar 1, 2013 | Substantially Equivalent |
| K083896 | DESTINY MAX COAGULATION ANALYZER | Jul 2, 2009 | Substantially Equivalent |