FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
K Number: K992252
·
Decision Aug 10, 1999
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
6
Applicant Total
8
Review Days
35
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
- LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
- K Number
- K992252
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chemicon Intl., Inc.
- Date Received
- July 6, 1999
- Decision Date
- August 10, 1999
- Product Code
- LYF
- 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 |
|---|---|---|---|
| LYF | Pneumocystis Carinii | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYF), ordered by most recent decision date.
FUNGI FLUOR KIT
FDA 510(k)
FDA Class 2
·Microbiology
STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
FDA 510(k)
FDA Class 2
·Microbiology
MERIFLUOR TM PNEUMOCYSTIS MODIFICATION
FDA 510(k)
FDA Class 2
·Microbiology
PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
MERIFLUOR(TM) PNEUMOCYSTIS
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Chemicon Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940027 | ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES | Sep 12, 1995 | Substantially Equivalent |
| K940473 | ENTEROVIRUS 71 MONOCLONAL ANTIBODY | Sep 12, 1995 | Substantially Equivalent |
| K940472 | COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY | Sep 8, 1995 | Substantially Equivalent |
| K936089 | COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY | Sep 8, 1995 | Substantially Equivalent |
| K936073 | ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS | Sep 8, 1995 | Substantially Equivalent |
| K940471 | COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES | Sep 8, 1995 | Substantially Equivalent |
| K936145 | COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY | Sep 8, 1995 | Substantially Equivalent |