FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BACTEC MYCO/F-SPUTA CULTURE VIALS
K Number: K972758
·
Decision Aug 8, 1997
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
67
Applicant Total
33
Review Days
53
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Basic Information
- Device Name
- BACTEC MYCO/F-SPUTA CULTURE VIALS
- K Number
- K972758
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2560
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton Dickinson Microbiology Systems
- Date Received
- June 16, 1997
- Decision Date
- August 8, 1997
- Product Code
- MDB
- 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 |
|---|---|---|---|
| MDB | System, Blood Culturing | FDA class 1 | Microbiology |
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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 |
| K984631 | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY | Nov 4, 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 |
| 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 |