JXB · Class I · 21 CFR 866.2660

FDA Product Code JXB: Kit, Identification, Yeast

Leading manufacturers include Advandx, Inc., Analytical Products, Inc. and Vitek Systems, Inc..

16
Total
16
Cleared
90d
Avg days
1977
Since

FDA 510(k) Cleared Kit, Identification, Yeast Devices (Product Code JXB)

16 devices
1–16 of 16
Cleared Sep 12, 2008
YEAST TRAFFIC LIGHT PNA FISH
K080719
Advandx, Inc.
Microbiology · 183d
Cleared Oct 25, 2006
C. ALBICANS PNA FISH
K062461
Advandx, Inc.
Microbiology · 63d
Cleared Feb 10, 2000
YEASTEST
K993554
Diagnostic Markers, Inc.
Microbiology · 113d
Cleared Feb 25, 1994
BACTICARD CANDIDA
K935124
Remel Co.
Microbiology · 120d
Cleared Jun 16, 1988
VITEK YEAST BIOCHEMICAL CARD
K881925
Vitek Systems, Inc.
Microbiology · 38d
Cleared May 13, 1986
YEAST IDENTIFICATION PANEL
K860575
American Micro Scan
Microbiology · 84d
Cleared Apr 05, 1983
YEAST IDENT
K830286
Analytical Products, Inc.
Microbiology · 68d
Cleared Dec 01, 1980
MS-2 IDENTIFICATION SYSTEM
K802309
Abbott Laboratories
Microbiology · 69d
Cleared Jul 08, 1980
NITRATE SWAB-RAPID TEST
K800803
Remel Co.
Microbiology · 89d
Cleared Jun 02, 1980
CAPIK-CANDIDA ALBICANS IDENT. KIT.
K800908
Immuno-Mycologics, Inc.
Microbiology · 42d
Cleared Dec 19, 1979
AMS YEAST BIOCHEMICAL CARD
K792231
Vitek Systems, Inc.
Microbiology · 44d
Cleared Aug 03, 1977
API 20C
K771008
Analytical Products, Inc.
Microbiology · 61d

About Product Code JXB - Regulatory Context