FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPUS(R) TOXO-G TEST SYSTEM
K Number: K921523
·
Decision Sep 14, 1992
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
105
Applicant Total
4
Review Days
167
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
- OPUS(R) TOXO-G TEST SYSTEM
- K Number
- K921523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3780
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pb Diagnostics, Inc.
- Date Received
- March 31, 1992
- Decision Date
- September 14, 1992
- Product Code
- LGD
- 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 |
|---|---|---|---|
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGD), ordered by most recent decision date.
Access Toxo IgG
FDA 510(k)
FDA Class 2
·Microbiology
Access Toxo IgM II
FDA 510(k)
FDA Class 2
·Microbiology
Alinity i Toxo IgM
FDA 510(k)
FDA Class 2
·Microbiology
ARCHITECT Toxo IgG
FDA 510(k)
FDA Class 2
·Microbiology
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
FDA 510(k)
FDA Class 2
·Microbiology
ADVIA Centaur Toxoplasma M (Toxo M)
FDA 510(k)
FDA Class 2
·Microbiology