Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1116720016
Device Listing 1116720016
Listing Summary
#
Listing key
1116720016
Premarket submission
K051432
Device
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
Applicant
Arkray, Inc.
Product code
CIG
Decision date
2005-06-17
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
10527
1832816
1832816
ARKRAY FACTORY USA, INC.
1
Y
2026-01-01
8260 NW 27th Street Suite 403 Miami FL US 33122
10528
9611444
3002807423
ARKRAY, INC.
1
N
2026-01-01
Yousuien-nai 59 Gansuin-cho, Kamigyo-ku Kyoto JP 602-0008
10529
3003422726
3003422726
Yosuke Yamamoto
1
N
2026-01-01
8260 NW 27th Street, Suite 403 Miami FL US 33122