Class I Microbiology device.
K803027 is an FDA 510(k) clearance for the CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 22, 1980.
This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.
View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices
| 510(k) Number | K803027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1980 |
| Decision Date | December 22, 1980 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | JSJ Culture Media, Selective And Non-differential |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 866.2360 |
Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.