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FDA 510(k)

C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)

K-Number: K982442 · 1998-08-25

ApplicantCare Wise Medical Products Corp.
Decision Date1998-08-25
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) is the device name listed in this FDA 510(k) record. The listed applicant is Care Wise Medical Products Corp.. It received FDA 510(k) clearance on 1998-08-25 under 510(k) number K982442. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)?

C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) is a medical device that received FDA 510(k) clearance on 1998-08-25. The listed applicant is Care Wise Medical Products Corp.. The 510(k) number is K982442.

When did C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) receive FDA 510(k) clearance?

C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) received FDA 510(k) clearance on 1998-08-25, under 510(k) number K982442.

Who is the listed applicant for C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)?

The FDA 510(k) record lists Care Wise Medical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)?

The FDA product code for C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) is IZD.

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 Care Wise Medical Products Corp. 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.

K922117C-TRAK BIOPSY SYSTEMK896588ONCOPROBE II SYSTEMK884770ONCOPROBE SYSTEM

Related Devices (Code: IZD)

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.

K123917DECLIPSESPECT VIEWERSurgiceye GmbHK101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbHK013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments GmhbK983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.K961321GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, 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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