FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMDINOCILLIN 10 MCG SENSI-DISC
K Number: K850357
·
Decision Mar 20, 1985
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
322
Applicant Total
632
Review Days
49
Basic Information
- Device Name
- AMDINOCILLIN 10 MCG SENSI-DISC
- K Number
- K850357
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1620
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- Date Received
- January 30, 1985
- Decision Date
- March 20, 1985
- Product Code
- JTN
- 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 |
|---|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JTN), ordered by most recent decision date.
HardyDisk AST Gepotidacin 10µg (GEP10)
FDA 510(k)
FDA Class 2
·Microbiology
Ceftobiprole BPR 5 µg Disc
FDA 510(k)
FDA Class 2
·Microbiology
Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
FDA 510(k)
FDA Class 2
·Microbiology
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
FDA 510(k)
FDA Class 2
·Microbiology
HardyDisk AST Cefiderocol 30µg (FDC30)
FDA 510(k)
FDA Class 2
·Microbiology
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
| K Number | Device Name | ||
|---|---|---|---|
| K003062 | BACTEC MGIT 960 SIR KITS | Jun 6, 2001 | Substantially Equivalent |
| K003553 | 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE | Mar 21, 2001 | Substantially Equivalent |
| K003461 | BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE | Feb 1, 2001 | Substantially Equivalent |
| K002938 | B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 | Nov 29, 2000 | Substantially Equivalent |
| K001364 | BD DIRECTIGEN FLU A+B | Jun 28, 2000 | Substantially Equivalent |
| K000762 | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 25, 2000 | Substantially Equivalent |
| K000829 | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 13, 2000 | Substantially Equivalent |
| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
| K992734 | BECTON DICKINSON SYRINGE | Oct 1, 1999 | Substantially Equivalent |
| K991551 | VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE | Sep 23, 1999 | Substantially Equivalent |