FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
K Number: K161810
·
Decision Feb 9, 2017
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
67
Applicant Total
6
Review Days
223
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Basic Information
- Device Name
- BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
- K Number
- K161810
- 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
- Date Received
- July 1, 2016
- Decision Date
- February 9, 2017
- 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
| K Number | Device Name | ||
|---|---|---|---|
| K243062 | BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) | Jun 20, 2025 | Substantially Equivalent |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial | Aug 8, 2016 | Substantially Equivalent |
| K113241 | BD EMERALD SINGLE USE, HYPODERMIC SYRINGE | Nov 28, 2011 | Substantially Equivalent |
| K041478 | BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR | Oct 28, 2004 | Substantially Equivalent |
| K042061 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE | Aug 26, 2004 | Substantially Equivalent |