FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03
K Number: K020226
·
Decision Aug 22, 2002
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
10
Applicant Total
2
Review Days
212
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Basic Information
- Device Name
- XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03
- K Number
- K020226
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hellen Professional Services
- Date Received
- January 22, 2002
- Decision Date
- August 22, 2002
- Product Code
- JWZ
- 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 |
|---|---|---|---|
| JWZ | Kit, Screening, Trichomonas | FDA class 1 | Microbiology |
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Other Clearances by Hellen Professional Services
| K Number | Device Name | ||
|---|---|---|---|
| K981536 | QUANTECH MYOGLOBIN ASSAY | Jun 29, 1998 | Substantially Equivalent |