FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MERIFLUOR(TM) -TRICHOMONAS
K Number: K892263
·
Decision May 24, 1989
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
10
Applicant Total
92
Review Days
50
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MERIFLUOR(TM) -TRICHOMONAS
- K Number
- K892263
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Meridian Diagnostics, Inc.
- Date Received
- April 4, 1989
- Decision Date
- May 24, 1989
- 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
TRICHOMATE(R) SUPER
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Meridian Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993914 | PREMIER TOXINS A&B, MODEL 616096 | Dec 10, 1999 | Substantially Equivalent |
| K990263 | IMMUNOCARD STAT! E. COLI O157:H7 | Aug 9, 1999 | Substantially Equivalent |
| K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | Jun 25, 1999 | Substantially Equivalent |
| K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST | Jun 25, 1999 | Substantially Equivalent |
| K983255 | MODIFICATION TO: PREMIER PLATINUM HPSA | Dec 17, 1998 | Substantially Equivalent |
| K982764 | PREMIER CRYPTOSPORIDIUM | Dec 3, 1998 | Substantially Equivalent |
| K982711 | PREMIER GIARDIA | Nov 25, 1998 | Substantially Equivalent |
| K980076 | PREMIER PLATINUM HPSA | May 12, 1998 | Substantially Equivalent |
| K980077 | PARA-PAK SPINCON | Apr 2, 1998 | Substantially Equivalent |
| K971585 | IMMUNOCARD STAT! ROTAVIRUS | Aug 20, 1997 | Substantially Equivalent |