Product code JWX— Microbiology
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
- Classification name
- Kit, Screening, Staphylococcus Aureus
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code JWX
FDA has cleared devices under product code JWX between 1981 and 2009, filed by 20 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2009
- 1997
- 1995
- 1993
- 1992
- 1991
- 1990
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
Top applicants under product code JWX
Recent clearances under product code JWX
- K090964 — BINAXNOX STAPHYLOCOCCUS AUREUS TEST
- K972030 — STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
- K964315 — REMEL STAPH LATEX KIT
- K945538 — STAPHAUREX PLUS(TM)
- K926173 — STAPH-A-LEX(TM) SYSTEM
- K923212 — SLIDEX STAPH-KIT
- K905617 — VISI-STAPH
- K902259 — AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
- K874019 — STAPHSLIDE
- K854278 — NEG COMBO BREAKPOINT PANEL POS COMBO
- K855220 — V-TREND KIT STAPH LATEX TEST
- K852997 — RAPI - STAPH
- K843560 — BACTO STAPHYLOCOCCUS LATEX TEST
- K831918 — LA-STAPH IDENTIFICATION SYSTEM
- K830783 — VERI-STAPH
- K822558 — LSM AGAR
- K822144 — IDS STAPHYLOCHROME TEST
- K821962 — BBL STAPHYSLIDE TEST
- K813614 — STAPH TRAC
- K811098 — SERO-STAT STAPHYLOCOCCUS TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.