FDA 510(k) Premarket Notification K010508: PASCO MIC AND MIC/ID PANELS

Submission Details & Decision

Normalized public record details for 510(k) notification K010508.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K010508

Applicant / Sponsor

Pasco Laboratories, Inc.

Device Name

PASCO MIC AND MIC/ID PANELS

Product Code

LTT

Decision Date

2001-04-23

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Microbiology (MI)

Clearance Type

Traditional

Third Party Flag

Date Received

2001-02-21

Related Establishments / Registrations

BECTON, DICKINSON & CO. Registration: 1119779 View Registration
Remel Cleveland, A Division of Remel Inc. Registration: 1530126 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
LIOFILCHEM S.R.L. Registration: 3012389632 View Registration
Liofilchem, Inc. Registration: 3013661582 View Registration
UPS Supply Chain Solutions, Inc. Registration: 3013718871 View Registration
bioMerieux, Inc. Registration: 3031977134 View Registration
TREK DIAGNOSTIC SYSTEMS, LTD. Registration: 8021914 View Registration

Public Record Disclaimer

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 Information may be outdated or incomplete.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.