FDA 510(k)

PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST

K-Number: K011116 · 2001-04-24

Decision Date2001-04-24

Product CodeLTT

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Pasco Laboratories, Inc.. It received FDA 510(k) clearance on 2001-04-24 under 510(k) number K011116. The device is classified under product code LTT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST?

PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST is a medical device that received FDA 510(k) clearance on 2001-04-24. The listed applicant is Pasco Laboratories, Inc.. The 510(k) number is K011116.

When did PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST receive FDA 510(k) clearance?

PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST received FDA 510(k) clearance on 2001-04-24, under 510(k) number K011116.

Who is the listed applicant for PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST?

The FDA 510(k) record lists Pasco Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST?

The FDA product code for PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST is LTT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pasco Laboratories, Inc. as applicant

K042331PASCO MIC AND MIC/ID PANELS K041776PASCO MIC AND MIC/ID PANELS K041214PASCO MIC AND MIC/ID PANELS K033119PASCO MIC AND MIC/ID PANELS K031727PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN K031205PASCO MIC AND MIC/ID PANELS

View all 66 devices →

Related Devices (Code: LTT)

K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc.K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc.K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc.K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )Beckman Coulter, Inc.K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)Beckman Coulter, Inc.K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)Beckman Coulter, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.