Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM

K-Number: K061301 · 2006-06-23

ApplicantCopan Diagnostics, Inc.
Decision Date2006-06-23
Product CodeJTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Copan Diagnostics, Inc.. It received FDA 510(k) clearance on 2006-06-23 under 510(k) number K061301. The device is classified under product code JTW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM?

COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Copan Diagnostics, Inc.. The 510(k) number is K061301.

When did COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM receive FDA 510(k) clearance?

COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM received FDA 510(k) clearance on 2006-06-23, under 510(k) number K061301.

Who is the listed applicant for COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM?

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

What is the FDA product code for COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM?

The FDA product code for COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM is JTW.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Copan Diagnostics, Inc. as applicant

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.

K042970COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEMK001780COPAN VIRAL TRANSYSTEMK993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMK946288COPAN VENTURI TRANSYSTEM LIQUID AMIES MEDIUMK946283COPAN VENTURI TRANSYSTEM LIQUID STUARTS MEDIUMK946287COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL

View all 10 devices →

Related Devices (Code: JTW)

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.

K121039COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEMCopan Flock TechnologiesK022874GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.K013819URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEMSierra Diagnostic, LLCK993161COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEMCopan Diagnostics, Inc.K983244SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)Trek Diagnostic Systems, Inc.K961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)Difco Laboratories, 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.

↑