Class Class II
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) (K223481)
Description
VITEK® 2 Streptococcus Tetracycline (=16 µg/mL) by bioMerieux, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223481
Clearance Date2023-02-03
Clearance TypeTraditional
Product CodeLON
Regulation Number866.1645
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223481
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) (K223481) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K111893 | VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE | bioMerieux, Inc. | 2012 |
Trace the full predicate network for K223481
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.