FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IDI-STREP B ASSAY
K Number: K022504
·
Decision Nov 18, 2002
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
17
Applicant Total
1
Review Days
112
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
- IDI-STREP B ASSAY
- K Number
- K022504
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Infectio Diagnostic, Inc.
- Date Received
- July 29, 2002
- Decision Date
- November 18, 2002
- Product Code
- NJR
- 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 |
|---|---|---|---|
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NJR), ordered by most recent decision date.
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
FDA 510(k)
FDA Class 1
·Microbiology
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
FDA 510(k)
FDA Class 1
·Microbiology
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
FDA 510(k)
FDA Class 1
·Microbiology
Panther Fusion GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
NeuMoDx GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology
Solana GBS Assay
FDA 510(k)
FDA Class 1
·Microbiology