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FDA 510(k)

CHROMOSTREAK

K-Number: K000718 · 2000-08-24

ApplicantNovamed , Ltd.
Decision Date2000-08-24
Product CodeJSN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHROMOSTREAK is the device name listed in this FDA 510(k) record. The listed applicant is Novamed , Ltd.. It received FDA 510(k) clearance on 2000-08-24 under 510(k) number K000718. The device is classified under product code JSN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMOSTREAK?

CHROMOSTREAK is a medical device that received FDA 510(k) clearance on 2000-08-24. The listed applicant is Novamed , Ltd.. The 510(k) number is K000718.

When did CHROMOSTREAK receive FDA 510(k) clearance?

CHROMOSTREAK received FDA 510(k) clearance on 2000-08-24, under 510(k) number K000718.

Who is the listed applicant for CHROMOSTREAK?

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

What is the FDA product code for CHROMOSTREAK?

The FDA product code for CHROMOSTREAK is JSN.

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 Novamed , Ltd. 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.

K974428DIPSTREAK

Related Devices (Code: JSN)

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.

K962745ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)Prepared Media Laboratory, Inc.K961755CYTOQUANT CHLAMYDIA TRANSPORT MEDIUMProteins Intl., Inc.K961756CYTOQUANT VIRAL TRANSPORT MEDIUMProteins Intl., Inc.K896296INPOUCH-TV POUCHBiomed Diagnostics, Inc.K881579AMIES TRANSPORT MEDIUM W/O CHARCOALAcumedia Manufacturers, Inc.K860967VIRTRAN VIRAL TRANSPORTER (MODIFIED)Diagnon Corp.

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.

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