FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
K Number: K984631
·
Decision Nov 4, 1999
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
44
Applicant Total
33
Review Days
309
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
- BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
- K Number
- K984631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton Dickinson Microbiology Systems
- Date Received
- December 30, 1998
- Decision Date
- November 4, 1999
- Product Code
- LSL
- 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 |
|---|---|---|---|
| LSL | Dna-Reagents, Neisseria | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LSL), ordered by most recent decision date.
Aptima Neisseria gonorrhoeae Assay
FDA 510(k)
FDA Class 2
·Microbiology
Aptima Combo 2 Assay (Panther System)
FDA 510(k)
FDA Class 2
·Microbiology
cobas CT/NG for use on cobas 6800/8800 systems
FDA 510(k)
FDA Class 2
·Microbiology
Xpert CT/NG
FDA 510(k)
FDA Class 2
·Microbiology
cobas® CT/NG v2.0 Test
FDA 510(k)
FDA Class 2
·Microbiology
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Becton Dickinson Microbiology Systems
| K Number | Device Name | ||
|---|---|---|---|
| K993577 | CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC | Dec 1, 1999 | Substantially Equivalent |
| K981517 | CEFDINIR, 5 UG, SENSI-DISC | Jun 9, 1998 | Substantially Equivalent |
| K980683 | TROVAFLOXACIN 10G, SENSI-DISC | May 1, 1998 | Substantially Equivalent |
| K974578 | GREPAFLOXACIN, 5 MG, SENSI-DISC | Feb 23, 1998 | Substantially Equivalent |
| K970333 | BACTEC MYCO/F LYTIC CULTURE VIALS | Jan 28, 1998 | Substantially Equivalent |
| K970512 | BACTEC MYCO/F LYTIC CULTURE VIALS | Jan 8, 1998 | Substantially Equivalent |
| K972758 | BACTEC MYCO/F-SPUTA CULTURE VIALS | Aug 8, 1997 | Substantially Equivalent |
| K972098 | FOSFOMYCIN, 200 MG, SENSI-DISC | Jul 28, 1997 | Substantially Equivalent |
| K970385 | SPARFLOZACIN, 5 MCG, SENSI-DISC | Mar 10, 1997 | Substantially Equivalent |
| K970212 | LEVOFLOXACIN, 5MCG, SENSI-DISC | Mar 6, 1997 | Substantially Equivalent |