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FDA 510(k)

DIPSTREAK

K-Number: K974428 · 1998-07-30

ApplicantNovamed , Ltd.
Decision Date1998-07-30
Product CodeJSI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIPSTREAK is the device name listed in this FDA 510(k) record. The listed applicant is Novamed , Ltd.. It received FDA 510(k) clearance on 1998-07-30 under 510(k) number K974428. The device is classified under product code JSI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIPSTREAK?

DIPSTREAK is a medical device that received FDA 510(k) clearance on 1998-07-30. The listed applicant is Novamed , Ltd.. The 510(k) number is K974428.

When did DIPSTREAK receive FDA 510(k) clearance?

DIPSTREAK received FDA 510(k) clearance on 1998-07-30, under 510(k) number K974428.

Who is the listed applicant for DIPSTREAK?

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 DIPSTREAK?

The FDA product code for DIPSTREAK is JSI.

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.

K000718CHROMOSTREAK

Related Devices (Code: JSI)

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.

K070691BBL CHROMAGAR 0157Becton, Dickinson & COK891593LISTERIA SELECTIVE ENRICHMENT MEDIUMOxoid U.S.A., Inc.K890199DENTOCULT SM-STRIP MUTANSOrion Corp.K882182SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326Lakewood Biochemical Co., Inc.K881575SELECTIVE STREPTOCOCCUS AGARAcumedia Manufacturers, Inc.K881572XL AGAR BASEAcumedia Manufacturers, 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.

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