FDA 510(k) Premarket Notification K080719: YEAST TRAFFIC LIGHT PNA FISH

Submission Details & Decision

Normalized public record details for 510(k) notification K080719.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K080719

Applicant / Sponsor

Advandx, Inc.

Device Name

YEAST TRAFFIC LIGHT PNA FISH

Product Code

JXB

Decision Date

2008-09-12

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

2008-03-13

Related Establishments / Registrations

BECTON, DICKINSON & CO. Registration: 1119779 View Registration
REMEL, INC. Registration: 1924669 View Registration
BIOMERIEUX, INC. Registration: 1950204 View Registration
Beckman Coulter, Inc. Registration: 2919016 View Registration
REMEL EUROPE LTD Registration: 3003750284 View Registration
UPS SUPPLY CHAIN SOLUTIONS, INC. Registration: 3009171251 View Registration
UPS Supply Chain Solutions, Inc. Registration: 3009637528 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3010132111 View Registration
UPS Supply Chain Solutions, Inc. Registration: 3013718871 View Registration
MEDICAL WIRE AND EQUIPMENT CO. LTD. Registration: 9610649 View Registration
BIOMERIEUX SA Registration: 9615754 View Registration
BIOMERIEUX FRANCE Registration: 9615755 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.