FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
K Number: K896926
·
Decision Jan 26, 1990
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
93
Review Days
46
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
- DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
- K Number
- K896926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Quidel Corp.
- Date Received
- December 11, 1989
- Decision Date
- January 26, 1990
- Product Code
- KTN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTN), ordered by most recent decision date.
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
FDA 510(k)
FDA Class 2
·Immunology
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
FDA 510(k)
FDA Class 2
·Immunology
BIORAPID MONONUCLEOSIS
FDA 510(k)
FDA Class 2
·Immunology
COLOR-MONOGEN
FDA 510(k)
FDA Class 2
·Immunology
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
FDA 510(k)
FDA Class 2
·Immunology
CLEARVIEW IM
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Quidel Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K131813 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Sep 6, 2013 | Substantially Equivalent |
| K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Aug 29, 2013 | Substantially Equivalent |
| K130398 | SOFIA(R) RSV FIA | Aug 13, 2013 | Substantially Equivalent |
| K131166 | SOFIA(R) HCG FIA | Aug 2, 2013 | Substantially Equivalent |
| K131606 | SOFIA INFLUENZA A+B FIA | Jul 5, 2013 | Substantially Equivalent |
| K131619 | QUICKVUE INFLUENZA A+B | Jun 28, 2013 | Substantially Equivalent |
| K122189 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Mar 8, 2013 | Substantially Equivalent |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Mar 8, 2013 | Substantially Equivalent |
| K113777 | QUIDEL MOLECULAR INFLUENZA A+B | Mar 15, 2012 | Substantially Equivalent |
| K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Dec 22, 2011 | Substantially Equivalent |