FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUST
K Number: K954994
·
Decision Oct 18, 1996
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
4
Review Days
353
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
- TRUST
- K Number
- K954994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Guardian Scientific, Corp.
- Date Received
- October 31, 1995
- Decision Date
- October 18, 1996
- Product Code
- GMQ
- 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 |
|---|---|---|---|
| GMQ | Antigens, Nontreponemal, All | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMQ), ordered by most recent decision date.
Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
FDA 510(k)
FDA Class 2
·Microbiology
ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer
FDA 510(k)
FDA Class 2
·Microbiology
ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
FDA 510(k)
FDA Class 2
·Microbiology
ASI Evolution
FDA 510(k)
FDA Class 2
·Microbiology
Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
FDA 510(k)
FDA Class 2
·Microbiology
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
FDA 510(k)
FDA Class 2
·Microbiology