FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
TRICHOMATE(R) SUPER
K Number: K875138
·
Decision May 13, 1988
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
10
Applicant Total
17
Review Days
150
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Basic Information
- Device Name
- TRICHOMATE(R) SUPER
- K Number
- K875138
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Mercia Diagnostics , Ltd.
- Date Received
- December 15, 1987
- Decision Date
- May 13, 1988
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWZ), ordered by most recent decision date.
GENZYME OSOM TRICHOMONAS RAPID TEST
FDA 510(k)
FDA Class 1
·Microbiology
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
FDA 510(k)
FDA Class 1
·Microbiology
XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03
FDA 510(k)
FDA Class 1
·Microbiology
MERIVIEW TM TRICHOMONAS
FDA 510(k)
FDA Class 1
·Microbiology
SUPER DUO
FDA 510(k)
FDA Class 1
·Microbiology
MERIFLUOR(TM) -TRICHOMONAS
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Mercia Diagnostics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K915479 | CAPTIA CMV-TA | May 4, 1992 | Substantially Equivalent |
| K904524 | CAPTIA(R) SYPHILIS M, MODIFICATION | Dec 26, 1990 | Substantially Equivalent |
| K900654 | MODIFIED CAPTIA(R) SYPHILIS-M | Mar 8, 1990 | Substantially Equivalent |
| K896295 | CAPTIA(R) CMV-M | Mar 6, 1990 | Substantially Equivalent |
| K900655 | MODIFIED CAPTIA(R) TOXO-M | Mar 6, 1990 | Substantially Equivalent |
| K896194 | CAPTIA(R) CMV-G | Mar 6, 1990 | Substantially Equivalent |
| K883924 | CAPTIA(R) RUBELLA-G | Aug 15, 1989 | Substantially Equivalent |
| K885300 | CAPTIA(R) RUBELLA-M | Aug 15, 1989 | Substantially Equivalent |
| K892802 | SUPER DUO | Jun 13, 1989 | Substantially Equivalent |
| K881425 | CAPTIA(R) SYPHILIS-G | Aug 4, 1988 | Substantially Equivalent |