JWX · Class I · 21 CFR 866.2660

FDA Product Code JWX: Kit, Screening, Staphylococcus Aureus

Leading manufacturers include Binax, Inc., Dms Laboratories and Bd Becton Dickinson Vacutainer Systems Preanalytic.

20
Total
20
Cleared
78d
Avg days
1981
Since

FDA 510(k) Cleared Kit, Screening, Staphylococcus Aureus Devices (Product Code JWX)

20 devices
1–20 of 20
Cleared Dec 16, 2009
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
K090964
Binax, Inc.
Microbiology · 254d
Cleared Sep 08, 1997
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
K972030
Oxoid , Ltd.
Microbiology · 98d
Cleared Feb 07, 1997
REMEL STAPH LATEX KIT
K964315
Remel, L.P.
Microbiology · 101d
Cleared Aug 10, 1993
STAPH-A-LEX(TM) SYSTEM
K926173
Trinity Laboratories, Inc.
Microbiology · 245d
Cleared Sep 28, 1992
SLIDEX STAPH-KIT
K923212
Biomerieux Vitek, Inc.
Microbiology · 89d
Cleared Jun 18, 1990
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259
Orthomet, Inc.
Microbiology · 28d
Cleared Mar 04, 1986
NEG COMBO BREAKPOINT PANEL POS COMBO
K854278
American Micro Scan
Microbiology · 131d
Cleared Mar 03, 1986
V-TREND KIT STAPH LATEX TEST
K855220
Texas Immunology, Inc.
Microbiology · 63d
Cleared Oct 01, 1984
BACTO STAPHYLOCOCCUS LATEX TEST
K843560
Difco Laboratories, Inc.
Microbiology · 21d
Cleared Jun 08, 1983
LA-STAPH IDENTIFICATION SYSTEM
K831918
Immuno-Mycologics, Inc.
Microbiology
Cleared Sep 14, 1982
LSM AGAR
K822558
Granite Diagnostics, Inc.
Microbiology · 21d
Cleared Jul 30, 1982
BBL STAPHYSLIDE TEST
K821962
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 29d
Cleared Feb 04, 1982
STAPH TRAC
K813614
Dms Laboratories
Microbiology · 37d

About Product Code JWX - Regulatory Context